24 INTRODUTION Surgical treatment of rectal cancer, proposed by Miles W E in 1908 has reduced the recurrence rate and increased survival, it is indicated for tumors in the lower part of the rectum (≤[.]
1 INTRODUTION Surgical treatment of rectal cancer, proposed by Miles W.E in 1908 has reduced the recurrence rate and increased survival, it is indicated for tumors in the lower part of the rectum (≤ cm) Adoption of the concept that the minimum safe distance of the rectal resection below the tumor requires only cm instead of cm according to previous views, which has reduced the rate of Miles surgery The results in many studies have demonstrated metastasis of cancer cells into the mesentery, which has made the total mesenteric resection technique reported by Heald in 1982 the standard surgery for radical treatment of rectal cancer in the middle and lower thirds In the last 30 years, surgical methods for radical treatment of rectal cancer of the middle and lower thirds are focusing on research and evaluation of the results of the total mesorectal excision technique Minimally invasive surgery has developed strongly all over the world, in which the laparoscopic total mesorectal excision (LaTME) is gradually considered the standard surgery in the treatment of the middle and lower rectal cancer and has many advantages in terms of both early and distant results compared with traditional open surgery However, for rectal cancer of the lower third, the technical and oncological results are still a big challenge for laparoscopic surgery, especially in patients with characteristics such as: male sex with narrow pelvis, obesity, large tumors or preoperative chemo-radiotherapy lead to a high rate of laparoscopic surgery to open surgery in the COLOR II and CLASICC studies, 17-29% Furthermore, access to the lower rectum in these cases is difficult because of the poor visibility and lack of visualization making it difficult to obtain an mesorectal plane (good plane of surgery achieved) as well as to obtain circumferential resection margin (CRM) and distal margin are oncologically safe Results in the CR07 and NCIC - CTG CO16 studies, the rate of mesorectal plane was only 52% and the rate of positive CRM was 11%, while the muscularis propria plane (poor plane of surgery achieved) and positive CRM was strongly associated with local recurrence and postoperative survival Penna's study showed that the risk of poor qualities mesenteric samples was times higher if the transabdominal resection the limit of cm from the anal margin Therefore, in order to obtain the highest quality of mesorectal while ensuring the oncologically safe distal margin, open surgery or laparoscopic surgery cannot stop the surgical area at the landmark > cm from the anal margin for lower third rectal tumors In order to overcome the limitations of open surgery and laparoscopic surgery in the treatment of rectal cancer, especially for rectal cancer in the lower third, the first transanal total mesorectal excision (TaTME) assisted by laparoscopy was published in 2010 by Sylla The method has improved the quality rate of mesorectal plane to 80 - 90%, and reduced the rate of conversion to open surgery by 2.8-3%, the rates of intracomplications and postcomplications are similar to other methods The surgical approach also contributes to an increased rate of sphincter preservation for low rectal cancer For these reasons, we performed the thesis: "Research and application of transanal total mesorectal excision for treatment of rectal cancer" The aims of this study are: Review of technical characteristics of transanal total mesorectal excision for treatment of rectal adenocarcinoma Evaluation of the results of transanal total mesorectal excision in the treatment of rectal cancer The advances of the thesis The thesis significance In the world, many authors have studied and applied this method, showing that the method is safe and effective with advantages in early results and oncology, especially in total mesorectal excision, tecnichque brought high rate of quality of intact mesorectal excision, help reduce recurrence rate and increase survival time after surgery for patients Applying the technique of transanal total mesorectal excision in the treatment of rectal cancer is still a new technique in Vietnam, there are not many surgical centers to research and apply the method The initial results really bring benefits to patients, as well as contribute to providing data for the study of long-term results later, which are the urgent reasons for us to performed the thesis: " Research and application of transanal total mesorectal excision for treatment of rectal cancer" Through research, the results of the thesis have confirmed the feasibility and safety of the TaTME The bottom-to-top dissection technique has increased the possibility of obtaining good quality mesorectum samples, while always ensuring a safe distal resection margin for oncology Moreover, the technique has also solved the problems encountered by open surgery or laparoscopic surgery such as: men with narrow pelvis, obesity, large tumors or preoperative chemo-radiation and increased the rate of sphincter preservation for low rectal cancer Chapter BACKGROUND 1.1 Applied anatomy in total mesorectal excision surgery The mesorectum is the continuation of the mesosigmoid from above The mesorectum encases the rectum as a thick cushion mainly posteriorly and laterally and the mesorectum is enclosed with the perirectal fascia The lower third of mesorectum gradually thins and disappears at the junction with the anal canal The superior, middle and inferior hemorrhoidal arteries provide blood supply to the rectum and anal canal The superior hemorrhoidal arterie is a direct continuation of the inferior mesenteric artery and descends in the mesosigmoid colon to the level of S3 where it bifurcates into right and left branches then further divides into anterior and posterior branches These branches penetrate rectal wall into the submucosa The middle hemorrhoidal artery is identified in 12% to 100% of cases and the artery is bilaterally present in 14% - 48% of cases and unilateral in 24% - 31% The size of the artery is variable and the point of insertion in rectum is - cm from the anus The vessel does not go through the lateral rectal ligaments and only accessory branches are found in 25% of cases and pass through the lateral ligaments Consequently, division of the lateral stalks during rectal mobilization is associated with a 25% risk for bleeding The presacral fascia (retrorectal fascia, Waldeyer’s fascia) is a thickened part of the parietal endopelvic fascia that covers the concavity of the sacrum and coccyx, nerves, the middle sacral artery, and presacral veins Operative dissection deep to the presacral fascia may cause troublesome bleeding from the underlying presacral veins Presacral hemorrhage occurs as frequently as 4.6% to 7.0% of resections for rectal neoplasms, and despite its venous nature, can be life threatening The Denonvilliers is a tough fascial investment that separates the extraperitoneal rectum anteriorly from the prostate and seminal vesicles or vagina Therefore, three structures lie between the anterior rectal wall and the seminal vesicles and prostate: anterior mesorectum, fascia propria of the rectum, and Denonvilliers’ fascia A consensus has generally been reached about the anatomy of the plane of posterior and lateral rectal dissection, but anteriorly, the matter is more controversial The anterior plane of rectal dissection may not necessarily follow the same plane of posterior and lateral dissection, and the use of the terms close rectal, mesorectal, and extramesorectal have been recently suggested to describe the available anterior planes The close rectal or perimuscular plane lies inside the fascia propria of the rectum and therefore it is more difficult and blood than the mesorectal plane The mesorectal plane represents the continuation of the same plane of posterior and lateral dissection of the rectum This is a natural anatomic plane and consequently more appropriate for most rectal cancers Finally, the extramesorectal plane involves resection of the Denonvilliers’ fascia, with exposure of prostate and seminal vesicles, and is associated with high risk of mixed parasympathetic and sympathetic injury because of damage of the periprostatic plexus TME principles The mesorectum is an important barrier to prevent disseminating cancer cells to - other organs In surgery, if not followed the correct principles, rupture of the mesentery will increase the rate of local recurrence after surgery The principle of surgery is dissection with sharp instruments, the area of surgery is between the rectal fascia and the pelvic fascia, avoiding manual dissection (blunt dissection) because it is easy to injure the rectal fascia TME is always accompanied by pelvic autonomic nerve preservation, so when cutting the lateral ligaments, the rectal wall should not be cut too far to preserve the nerve The middle rectal artery branching into the lateral ligament is usually not large in size, so just cutting with a Ligasure or a Hemonic is enough to stop the bleeding The technique aims to obtain the entire rectum and mesorectum into a mass with the mesorectum capsule intact, while preserving the pelvic autonomic nerve branches A good specimen is described as having a smooth, glossy surface and free of defects Grading of specimen (according to Quirke P.) Mesorectal plane (good plane of surgery achieved) Intact mesorectum with only minor irregularities of a smooth mesorectal surface; no defect deeper than mm; no coning; and smooth circumferential resection margin on slicing Intramesorectal plane (moderate plane of surgery achieved) Moderate bulk to mesorectum, with irregularities of the mesorectal surface; moderate distal coning; muscularis propria not visible with the exception of levator insertion; and moderate irregularities of circumferential resection margin Muscularis propria plane (poor plane of surgery achieved) Little bulk to mesorectum with defects down onto muscularis propria; very irregular circumferential resection margin; or both 1.2 Transanal total mesorectal excision Indication Indication by tumor location: Most surgeons assign rectal cancer in the middle third and lower third For Lacy and some other authors, the method is also indicated for upper third tumors Indication by stage T: Indicated for T1-2 tumors For T3 tumors with CRM/MRI+ or T4 treated with chemotherapy - radiotherapy first as recommended by The National Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) Re-evaluating the stage after adjuvant therapy has selected only T3 tumors, but other authors have selected T4a tumors Contraindications The authors agreed on contraindications for T4b tumors Several other studies have contraindications for T4 tumors Other contraindications: Patients with previous TaTME surgery or abdominal or pelvic surgery or liver or lung metastases, body mass index > 28-30 kg/m2 Surgical technique Basically, the TaTME method is divided into phases: the transanal approach and the abdominal approach Depending on the surgical centers, the authors will perform the transanal approach first or the transanal approach first or perform both stages at the same time by two surgical teams A purse-string suture was placed through the rectal mucosa to tightly occlude the rectum With tumor at very low position (< cm from the anal margin): suture to close the rectal lumen and perform sphincter-preserving dissection and place the Genpoint Path valve For higher-grade tumors, a Genpoint Path valve is placed and then sutures are performed to close the rectum below the tumor Distal to the purse string, a full-thickness rectal transection was initiated circumferentially Once within the presacral plane, the mesorectum was mobilized, and the posterior dissection proceeded cephalad in the avascular presacral plane in accordance with total mesorectal excision (TME) principles 1.3 Transanal Total Mesorectal Excision for Rectal Cancer in the treatment of rectal cancer Short term results Early results of TaTME in studies showed that: Mean operative time ranged from 143 - 560 minutes, mean hospital stay was from 4.3 - 16.6 days The results of oncology: the positive distal margin ranged from - 2%, the positive CRM (CRM+) from 2.4 - 5% and the rate of mesorectal plane ranged from 72 - 97.5% The rate of intraoperative complications ranged from - 6%, in which urethral injury is considered a typical intraoperative complication of TaTME method, accounting for 0.7 - 1.1% The rate of post complications ranges from 34.2 - 40%, however, serious complications have a low rate such as anastomotic leakage about 3.8% - 8.6%, anastomotic stricture about 1.4%, pelvic abscess was found in 2.4 - 3.4% The rate of conversion to open surgery ranges from to 7.5% and the mortality rate from to 0.5% Mid and long terms results Tuech et al reported results in 56 patients, 29 months average follow-up (18-52), local recurrence rate 1.7%, distant metastasis 7.1%, rate overall survival was 96.4% and the 5-year disease-free survival rate was estimated at 94.2% Lacy et al.'s study in 140 patients, the average follow-up time was 15.1 months (7.1 - 20.7) with local recurrence rate 0.8%, distant metastasis 6.1%, local recurrence and distant metastasis 1.5% and disease-free survival rate 90.8%, overall survival 97.1% Results in the multicenter study of Caycedo et al evaluated on 608 patients with local recurrence rate of 3.6% and distant metastasis rate of 9.4% over a mean follow-up of 27 months, the rate diseasefree survival at 24, 36 and 48 months is forecasted for 91%, 88% and 85%, respectively Functional Outcomes - Bladder function: Koedam et al evaluated bladder function after TaTME surgery and found 10% urinary retention Comparing the time before surgery with month and months after surgery, there was no significant change in urinary incontinence symptoms, increased frequency of urination or difficulty urinating Tuech's study also showed that all bladder dysfunction was reversible by the 4th month after surgery - Sexual function: Penna et al reported that a higher number of patients in the TaTME group maintained sexual function compared with the laparoscopic surgery group (71% vs 39%, p = 0.02) Evaluation of erectile function also showed better in TaTME surgery, although the comparison was not statistically significant, the corresponding scores were 17 vs (p = 0.119) The study of Koedam et al showed that sexual desire was significantly reduced at month after TaTME surgery but returned to normal at months postoperatively - Defecation function: Xu et al.'s study on 115 patients undergoing rectal cancer surgery with intersphincterectomy, divided into groups: group A had 41 patients underwent open surgery, group B had 74 patients with TaTME surgery, mean Wexner scores at preoperative and 12 months post-operatively in group A compared with group B, were 0.4 ± 1.2 versus 0.2 ± 0.8 (p = 0.112) and 2.7 ± 2.7 vs 3.6 ± 3.8 (p = 0.099), respectively Koedam et al studied on TaTME surgery, found that there was a decrease in bowel function at month after surgery compared with before surgery, but most recovered after months of surgery Comparing the time before surgery and months after surgery, the difference was not statistically significant (p = 0.339) In Mazin Juma's study, about 40% of patients after surgery had complete control of stools, the rate of incontinence fluctuated from 5.7% to 60% Chapter PATIENTS AND METHODS 2.1 Patients Includes patients who have been diagnosed with rectal cancer of the middle (6 -10 cm from the anal margin) and the lower (0 - cm from the anal margin) and have the Transanal total mesorectal excision at 108 Military Central Hospital from 7/2017 to 08/2019 Follow-up after surgery until the end of September 2020 2.1.1 Patient selection - Primary adenocarcinoma of the middle third and lower third of the rectum was diagnosed by endoscopic biopsy or histopathology - Patients underwent transanal total mesorectal excision - Preoperative tumor invasion ≤ T4a - The patient consented to surgery by the method of Transanal total mesorectal excision 2.1.2 Exclusion criteria - Rectal cancer has complications such as abscess, bowel obstruction, bleeding or tumor rupture - Low rectal cancer has invaded the sphincter, anal levator muscle and requires Miles surgery - Recurrent rectal cancer - Patients with contraindications to laparoscopic surgery: heart failure, liver failure, decompensated respiratory failure, pulmonary tuberculosis, cerebrovascular accident 2.2 The Method Clinical intervention, prospective, and without comparison 2.3 Research targets 2.3.1 General features Including: ages, gender, body mass index (BMI), ASA score, adjuvant treatment 2.3.2 Clinical characterics Including: time of the first symptom appeared, clinical symptoms, rectal examination 2.3.4 Investigation features Includes: colorectal endoscopy, blood count, CEA, multi computed tomography (CT) scan of the chest, the abdomen, magnetic resonance imaging (MRI) of the pelvis 2.4 Technical Process of Transanal total mesorectal excision Indication Indication has based on author Lacy, including patients with cervical cancer in the middle and lower thirds, ASA score from I to III, preoperative adjuvant treatment according to the guidelines of The National Comprehensive Cancer Network (NCCN) Operative technique The surgery is divided into main steps: Transanal approach and Abdominal approach Transanal approach: a Lone Star Retractor is inserted For tumors located ≤ cm from the anal margin: Close the rectal lumen about cm below the tumor with Prolen 2/0 The anal canal was then irrigated with a diluted betadine solution 7 A transverse incision around the anal canal begins about cm below the dentate line (for total internal sphincterotomy) or across the dentate line (for partial internal sphincterotomy) Dissect into the area of the sphincter and then along the sphincter up to the dentate line about 1.5 - cm is horizontal with the position of the upper margin of the levator muscle, cut off the part of the levator muscle attached to the rectum to enlarge the surgical field Place the Gelpoint Path valve, the CO2 pump maintains a pressure of about - 10 mmHg For tumors located > cm from the anal margin: Place the Genpoint Path valve, pump CO2 pressure - 10 mmHg Close the rectal lumen at or above the anorectal ring approximately cm with Prolen 2/0 The anal canal was then irrigated with a diluted betadine solution Perform a transverse cut perpendicular to the wall of the rectum at or just below the anorectal ring outward, exposing and resecting the levator muscle attached to the rectum At this step, the correct identification of the lipoma-like surface of the mesorectum was the key point in the procedure allowing the identification of the correct dissection plane Laparoscopic dissection: starting from the posterior aspect at o'clock to o'clock and o'clock to o'clock to the avascular space between the surface of the MTTT fascia and the anterior sacral fascia Continue dissection extending to the sides to o'clock and o'clock and then to the front Anterior dissection from 12 o'clock to both sides to o'clock and 10 o'clock Bilateral dissection was developed from anterior and posterior anatomical areas The sequence of dissection is repeated in the order of posterior – anterior – lateral, and always ensure that the surgical area goes between the inside of the pelvic wall fascia and the outside of the fascia propria of rectum to gradually ascend The surgical area stops when the front is at the level of the pouch of Douglas Finally, the peritoneal reflection was identified anteriorly and opened to enter into the peritoneal cavity within the pouch of Douglass In cases where the surgical area has not reached the pouch with Douglas or the tumor is on the anterior surface, large size, pressing on the pouch of Douglas, we not proceed to open the pouch of Douglas to enter the abdomen Abdominal approach: Using trocars, placement of trocar: 10mm trocar placed at umbilicus, 10mm or 12mm trocar placed in right iliac fossa about cm anterior superior iliac crest, 5mm trocar in right lower quadrant in midclavicular line, 5mm trocar placed in iliac fossa left CO2 pressure is maintained at 12-14mmHg Once the inferior mesenteric vessels are tied and a complete mobilization of the mid-distal transverse colon, splenic flexure and descending sigmoid colon is performed, the peritoneum of the Douglas pouch is sectioned and the previous transanal plane of dissection is easily found 2.5 Evaluation of the results of transanal total mesorectal excision 2.5.1 Results of technical characteristics - Time to set the Genpoint Path valve - Terminated anterior dissection - Open the pouch of Douglas - Specimen extraction site - Anastomosis 2.5.2 Intra-operative results - Intersphincter preserving technique - Protective ileostomy - Operative time - Intraoperative blood loss - Intraoperative complications - Conversions to open 2.5.3 Early outcomes: - Bowel movements time - Time of using pain- killers - Hospital stays - Intestinal continuity was restored - Postoperative complications - Mortality - Histopathologic characteristics (quality of mesorectum, T stages, N stages, quality of distal and proximal margin resection and CRM, lymph node harvest, cell type, degree of differentiation, classification of disease stages) 2.5.4 Long-term outcomes Evaluate functions Results of bladder function: evaluate once a month in the first months after surgery (for patients with normal preoperative bladder function) The rating scale is based on The International Prostate Symptom Score - IPSS Results of sexual function: evaluated at months postoperatively for male patients < 60 years old with normal preoperative sexual function Using the International Index of Erectile Function - IIEF Results of defecation function (monthly period) recorded: characteristics of stool (solid, liquid, constipation), defecation frequency/day, fecal incontinence Evaluation of bowel function according to Wexner's criteria Oncology results Local recurrence, distant metastasis Postoperative survival + Overall survival + Overall survival rate at year, years and years + Disease-free survival + The survival rate according to disease stages Research on the relationship of factors to surgical outcomes - Analyze the relationship of factors to some surgical results + Relation of factors: sex, BMI, tumor location, tumor size, tumor invasion and preoperative adjuvant treatment to quality of mesorectum + Relation of factors: sex, BMI, tumor location, tumor size, preoperative adjuvant treatment to operative time and intraoperative complications + Relation of factors: tumor location, method of making anastomosis, distance from anastomosis to anal margin and preoperative adjuvant treatment to anastomotic leakage - Analysis of the relationship of factors to some oncology outcomes: + Relation of factors: tumor location, pT stages, pN stages, quality of mesorectum and CRM to local recurrence + Relation of the quality of mesorectum, CRM, pT and pN to distant metastases 2.2.2.7 The method of collecting data and analyzing data Record information into encrypted databases at history patients, all analyses were performed with SPSS statistical software version 20.0 Evaluation of survival rate after surgery by Kaplan - Meier method Find out the relationship between ratios based on ANOVA, Fisher test and χ2 test with 95% accuracy (p < 0.05) 2.2.4.8 Research ethics The study was approved by the Ethics Committee of 108 Military Central Hospital (QD: 786/QD-BV dated March 8, 2017) All patients participating in the study were explained before surgery about the advantages and disadvantages of the method, prognosis and expected results during and after surgery Patients voluntarily participating in the study were selected into the study group in accordance with the selection criteria as in the research method The doctor in charge of the patient in the study is responsible for monitoring and re-examination after surgery Regularly update knowledge to adjust and apply to bring the best results for patients Chapter RESULTS OF STUDY 3.1 Characteristics of the patients 3.1.1 General features - Average age 62.37 years old (from 28 to 86), men account for 68.42% - The average body mass index (BMI) was 21.23 kg/m2 (from 16.00 to 28.10), the majority with normal BMI accounted for 64.91%, obese patients accounted for 15.79 % - ASA score: I: BN (3.51%); II: 16 BN (28.07%) and III: 39 BN (68.42%) - Preoperative adjuvant treatment: chemotherapy 1/57 (1.75%), radiation therapy 21/57 (36.84%), chemo - radiotherapy 27/57 (47.37%) and no treatment 8/57 (14.04%) 3.1.2 Clinical features - The average time of clinical manifestations is 3.96 months (from 0.5 to 13) - Bloody stools 43/57 (75.44%), weight loss 54.39%, anal pain 22/57 (38.6%), constipation 11/57(19.3%), bloody stools fresh 11/57(19.3%), loose stools 8/57 (14.04%), constipation - alternating loose stools 5/57 (8.77%) and flat stools 5/57(8.77%) - Tumor location: the middle third is 50.88% and the lower third is 49.12% - Distance from tumor to anal margin: the average group was 5.01 cm The mean of the lower third group was 3.76 cm and the middle third group was 6.23 cm - Tumors mobility: mobile tumor ratio was 68.42%, difficult mobile tumor ratio was 29.82%, fixed tumor ratio was 1.75% 3.1.3 Paraclinical features - Blood tests: 10 Red blood cells: 4.55 T/l, white blood cells: 6.43 T/l, hemoglobin: 134.74 g/l, urea: 5.59 mmol/l, creatinine: 72.09 µmol/l, SGOT: 26.04 U/l, SGPT: 26.44 U/l, CEA: 3.68 ng/ml - Colorectal endoscopy: + Tumor form: wart: 38/57 (66.67%), ulcer: 7/57 (12.28%), infiltrate: 2/57 (3.51%) and combined (wart and ulcer): 10/57 (17.54%) + - Tumor invasion by lumen of rectum: < 1/4 was 68.42%; 1/4 to < 1/2 was 14.04%; 1/2 to ≤ 3/4 was 5.26% and > 3/4 was 12.28% + Cell type: adenocarcinoma: 54/57 (94.74%), dysplasia: 3/57 (5.26%) - Magnetic resonance: 4(7.02%) Tx; 10(17.54%) T2; 37 (64.91%) T3, 6(10.53%) T4a; 4(7.02%) Nx; 12(21,05) N0; 27(47.37%) N1; 14(24.56%) N2 - Computed tomography: 55(96.49%) M0 and 2(3.51%) M1a - Diagnosis of tumor stage (T), lymph node (N) and distant metastasis (M) before surgery: (7.02%) T2; 51(89.47%) T3; 2(3.51%) T4; 7(12.28%) N0; 35(61.40%) N1; 15(26.32%) N2; 55(96.49%) M0 and 2(3.51%) M1a - Classification of disease stage before surgery: (5.26%) unspecified; 5(8.77%) stage I; 6(10.53%) stage IIa; 2(3.51%) stage IIb; (1.75%) stage IIIa; 32(56.14%) stage IIIb; (10.53%) stage IIIc and 2(3.51%) stage IV 3.3 Results of Transanal total mesorectal excision 3.2.1 Technical characteristics results When to set the Genpoint Path valve - Placed before rectal closure: 42/57 (73.68%) - Placed after rectal closure: 15 (26.32%) Degree of perianal dissection and pouch of Douglas resection - Level of transanal approach: up to pouch of Douglas 56/57 (98.25%), below pouch of Douglas: 1/57 (1.75%) - Open the pouch of Douglas: 44/57 (77.19%): Not open: 13/57 (22.81%) Specimen extraction site and perform anastomosis - Specimen extraction site: + Transanal: 53/57 (92.98%) + Pfannenstiel: 4/57 (7.02%) - Anastomosis: + Hand sewn: 39/57 (68.42%) + Stapled: 18/57 (31.58%) 3.2.2 Intra-operative results Intersphincter preserving + No intersphincter resection: 36/57 (63.16%) + Partial intersphincter resection: 10/57 (17.54%) + Total intersphincter resection: 11/57(19.30%) Protective ileostomy + Working: 29/57 (50.88%) + Not working: 28/57 (49.12%) Operative time + Total group: 150.88 ± 26.07 (100 - 235) + Transanal approach: 93.33 ± 19.92 (50 - 150) + Anastomosis: 23.84 ± 8.29 (10 - 60) Blood loss: 83.49 ± 56.82 ml (from 20 to 325) 11 Intra-operative morbidity + Intra - transanal bleeding: 1/57 (1.75%) + Intra - transanal vaginal perforation 1/57 (1.75%) Conversion to open surgery There were no cases that required conversion to open surgery 3.3.3 Early results Bowel movement time: the mean time after surgery was 2.86 ± 1.17 days Time of using pain- killers: day was 71.93% and days was 28.07% Times of hospital stay was: 11.26 ± 5.41 days (4 - 29) Intestinal continuity was restored A total of 29 patients had ileutomy drainage, 25 patients (86.21%) had intestinal continuity was restored and patients (13.79%) have not Postoperative complications - Early postoperative complications: urinary retention 7(12.28%), small bowel obstruction 1(1.75%), anastomotic leakage 1(1.75%) - Late postoperative complications: small bowel obstruction (1.75%), anastomotic stricture (10.53%), anastomotic leakage (1.75%), loss of sphincter function (1.75%) - Classification of complications according to Clavien - Dindo grade I, II: (15.79%), Clavien - Dindo grade III: (15,79%) Surgical death: there were no deaths within 30 days before surgery Pathological results: - Quality of the mesorectum: Mesorectal plane: 51/57 (89.47%), Intramesorectal plane: 5/57 (8.77%), Muscularis propria plane: 1/57 (1.75%) - Average size of tumors: 3.03 ± 1.48 cm (1.0 - 8.0) - Average distance from tumor to distal margin: 2.33 ± 0.58 cm (1.4 - 3.7) - T stage: T0 (8.77%); T1 (7.02%); T2 21 (36.84%); T3 27 (47.37%) - N stage: N0: 40 (70.18%); N1a: (12.28%); N1b: (10.53%); N2a: (5.26%); N2b: (1.75%) - Average number of lymph nodes harvest: 13.75 ± 4.45 nodes (3 - 23) - 100% of proximal and distal margin resectionare were negative and CRM (+): (1.75%) - Classification of disease stage after surgery: unspecified: (7.02%); stage I: 17 (29.82%); IIa:17 (29.82%); IIIa: (10.53%); IIIb: 10 (17.54%); IIIc: (1.75%); IV: (3.51%) 3.3.4 Long-term outcomes Functional results - Bladder function results: monthly assessment in the first months after surgery for patients with normal preoperative bladder function: All dysfunctional patients recovered months after surgery Table 3.31 Bladder function outcomes After surgery (months) 1st month Classification according to IPSS scale, n (%) Group Group Group 23 (58.97) (7.69) 13 (33.33) 12 2nd month 26 (66.67) (2.56) 12 (30.77) 3rd month 34 (87.18) (0) (12.82) 4th month 38 (97.44) (0) (2.56) 5th month 39 (100) (0) (0) 6th month 39 (100) (0) (0) - Sexual function results: evaluation in 11 patients under 60 years of age and with normal preoperative sexual function at the 6th month after surgery, the results are in Table 3.33 Table 3.33 Sexual function results Evaluation criteria Minimum (n = 11) score Erectile function Orgasmic function Sexual desire Intercourse satisfaction Overall satisfaction Erectile dysfunction group Maximum score 24 13 10 Group Group Group Medium score 15,36 ± 4,20 5,82 ± 1,94 5,82 ± 1,54 7,82 ± 2,89 6,36 ± 2,11 (27,27) (63,64) (9,09) - Outcomes of sphincter saving surgery: Average Wexner scores tend to decrease over time (chart 3.6) At months, 12 months and 24 months after surgery, the average Wexner score recorded was: 8.48; 4.00 and 2.24, respectively Comparison of the mean Wexner score between the groups of sphincter preservation (total preservation, partial preservation and total resection) was different at the time of months, 12 months and 24 months (p < 0.05) Wexner score over time 16 14.59 13.74 14 12.33 11.27 12 9.8 10 8.48 7.8 7.05 6.2 5.53 4.8 3.02 2.24 1st 2nd 3rd 4th 5th 6th 7th 8th 9th 10th 11th 12th 18th 24th month month month month month month month momth month month month month month month Chart 3.7 Rehabilitation of sphincter function Oncology results Table 3.29 Rate of local recurrence and distant metastasis Ratio Time of recording Characteristics n % (month after surgery) 13 Local recurrence 3,51 - 19 (Evaluated in 57 patients) Distant metastasis 14,55 - - - - 10 - 23 - 24 - 29 (Evaluated in 55 patients) Mean time of distant 13,63 ± 10,13 tháng metastasis Comment: At the end of follow-up, there were patients with local recurrence, accounting for 3.51% and patients with distant metastasis, accounting for 14.55% Surviving after surgery Overall survival Chart 3.7 Overall survival probability of the whole study group Comment: the number of patients alive was 50 patients (87.72%) and patients died (12.28%), the mean overall survival time of the whole group according to Kaplan - Meier was 35,535 ± 0.852 months (95% CI: 33.865 – 37.205) Bảng 3.30 Xác suất sống thêm toàn thời điểm năm, năm năm Time of life Survival ≥ year ≥ years ≥ years Cumulative number of dead patients Cumulative survival rate (%) 100 90.6 77.7 TB ± SE (month) 35.535 ± 0.852 95% CI 33.865 – 37.205 Comment: the probability of overall survival at the after year, years and years after surgery calculated according to Kappan - Meier is 100%, respectively; 90.6% and 77.7% Disease-free survival 14 Chart 3.8 Probability of disease - free survival Comment: Among 55 patients with no distant metastasis before surgery, 43 patients (78.18%) were disease-free survival and 12 patients (22.8%) had recurrence, metastasis or died Mean disease-free survival according to Kaplan Meier was 32,451 ± 1,432 months (95% CI: 29,645 – 35,258) Survival according to the stages of desease Chart 3.9 Probability of survival according to disease stages Comment: the survival rate according to stages: I, IIa, IIIa, IIIb and IV were 94.1%, 88.2%, 83.3%, 90.0% and 50.0%, respectively The relationship of some factors to oncology results Relation of some factors to technical results - Relation of factors: sex, BMI, tumor location, tumor size, tumor invasion and preoperative adjuvant treatment to quality of mesorectum Only the quality factor of BMI was related to quality of mesorectum (p < 0.001) - Relation of factors: sex, BMI, tumor location, tumor size, preoperative adjuvant treatment to surgery time There was no relationship between the factors: sex, BMI, location, tumor size and preoperative adjuvant treatment for the time of surgery (p > 0.05) - Relationship between sex, BMI, tumor location, tumor size, preoperative adjuvant treatment to intraoperative complications There was no association between gender factors, BMI, tumor size, tumor location and preoperative adjuvant treatment to intraoperative complications (p > 0.05) - Relationship between tumor location, anastomosis, anastomosis-anal margin distance, preoperative adjuvant treatment with anastomosis fistula There was no association with the following factors: tumor location, method of anastomosis, distance from the anastomosis to anal margin and preoperative adjuvant treatment to anastomosis fistula (p > 0.05) 15 Relation of some factors to oncology outcomes - Relationship between tumor location, invasion of tumor, lymph node metastasis, quality of mesorectum, CRM to local recurrence The factor of lymph node metastasis was associated with local recurrence (p < 0.001) - Relation of quality of mesentery and circumcision area, tumor invasion level, lymph node metastasis to distant metastasis results after surgery The quality factors mesorectum and lymph node metastasis were related to distant metastasis after surgery (p = 0.035 and p < 0.001, respectively) Chapter DISCUSSION 4.1 General features 4.1.1 Ages and sex Rectal cancer is a disease that can occur at any ages, however, the disease is rare at the age of < 40 years, the incidence begins to increase significantly at the age of 40 - 50 years and increases gradually with age, and age is one of the risk factor for rectal cancer In Western countries, about 90% of patients with rectal cancer are found after the age of 50 and most are between 60 - 69 years of age Pham Van Binh's study in 135 low rectal cancer patients, the male/female ratio was 1.04 and the mean age was 55.31 years (22 - 80) Lacy et al reported 140 patients undergoing TaTME surgery, the male/female ratio was 89/51(1.37) and the mean age was 65.5 years Tuech et al studied 56 patients undergoing TaTME with a male/female ratio of 41/15 (2.73) and a mean age of 65 years (39 - 83) All of the above studies show that there is no contraindication in terms of age for total mesorectal excision technique for rectal cancer in surgical methods In this study, there were 57 patients, including 39 men (68.42%) and 18 women (31.58%), the male/female ratio was 2.17 The average age is 62.37 ± 12.41 years old (28 - 86 years old), the common age is 61 - 80 years old (57.89%), this average age is equivalent to the studies of Lacy and Tuech 4.1.2 Body mass index The prevalence of overweight and obesity is increasing worldwide, which is a factor that makes the technique difficult and causes an increased risk of intraoperative morbidity and pots - operative complications of surgery The study by Qiu Y et al showed the conversion rate of Laparoscopic Total Mesorectal Excision (LaTME) in the obese group (28.3) to open surgery was significantly higher than that of the non-obese group (13.6%), p < 0.001 In addition, other obesity-related post - operative complications such as anastomosis fistula, wound infection (p < 0.001) and pulmonary complications (p = 0.012) The study of Sun Y et al showed that the time of laparoscopic surgery was longer in the group with BMI ≥ 25 kg/m (224.3 minutes) than in the group of patients with BMI < 25 kg/m2 (207.9 minutes), p = 0.004 Our study had a mean BMI of 21.22 kg/m2 (16.0 - 28.1), overweight patients accounted for 14.04% and no obese patients The mean index of BMI in this study was lower than those of Simillis C (26 kg/m2) and Perdawood (28 kg/m2) The relationship of BMI to some TaTME surgical outcomes will be analyzed later 4.1.3 ASA score The ASA score is thought to be an independent predictor of risks such as complications, re-hospitalization, and mortality after surgery, with the higher the ASA 16 score, the higher the risk The prediction of PT mortality by the ASA index has a sensitivity and specificity of 0.74% and 0.67%, respectively Similar to many other authors, we only indicated surgery in patients with ASA I-III The rate of ASA I, ASA II and ASA III of this study was 3.51%, 28.07% and 68.42%, respectively 4.2 Clinical features 4.2.1 Time of clinical manifestations The average time from the onset of the first symptom to the patient's visit was 3.96 months, equivalent to the study of Pham Van Binh of 3.8 months and shorter than the study of Mai Duc Hung of 5.74 months 4.2.2 Clinical symptoms Blood in stool was the most common symptom and also the reason why patients hospitalized in the studies of Lam Viet Trung was 98.4%, the study of Truong Vinh Quy was 92.3% Results in this study, blood in stool was the symptom with the highest percentage (75.44%) 4.2.3 Tumor characteristics Rectal examination is the classic and most important method, which is capable of assessing the characteristics of rectal cancer such as: tumor invasion, distance from tumor to anal margin, size of tumor associated with rectal cancer related to the lumen of the rectum Our study had an average distance from the tumor to the anal margin of 5.01 cm (2 - 8.2) Tumor location in the middle third has 29 patients (50.88%) and the lower third has 28 patients (49.12%) The median distance from the lower border of the tumor to the anal margin in TaTME in some other studies: Burke's study was 4.4 cm; Atallah's study is 5cm (1 - 9) Assessing the degree of tumor mobility, the results of this study showed that 68.42% of mobile tumors; 29.82% of difficult mobile tumor and 1.75% of fixed tumor These rates in another study were 59.6%; 38.5% and 1.9%, respectively 4.3 Paraclinical features 4.3.1 Colorectal endoscopy The method allows an overview of the shape, size, extent of invasion of the rectal lumen and the tumor distance from the anal margin Moreover, endoscopy can also take samples for pathology to help guide treatment as well as disease prognosis The results of the study showed that the shape of the tumor recorded on endoscopy could be wart accounted for 66.67%, ulcerative form 12.28% and a combination of warts and ulcers 17.54%, infiltrative form accounted for 3.51% The results of endoscopic biopsy revealed 94.74% as adenocarcinoma and 5.26% as dysplasia (all these cases were diagnosed as adenocarcinoma by tumor pathology after surgery) 4.3.2 Magnetic resonance imaging and computed tomography Magnetic resonance imaging: accurate diagnosis of rectal cancer stage before surgery is very important in treatment planning and is the strongest predictor of cancer recurrence The MERCURY study showed that the sharp, high-resolution magnetic resonance images allow accurate identification at a distance of 1mm when assessing the tumor organization of the invasive mesorectum with an accuracy of about 87% and a specificity about 92% Research results of Simillis C et al preoperative diagnosis for T stage: 6% T1, 21% T2, 65% T3 and 8% T4; for nodal stage: 2% Nx, 52% N0, 29% N1 and 17% N2 The results of our study recorded 7.02% TxNx, these are patients who have 17 completely responded to preoperative chemo-radiotherapy About computed tomography: patients (3.51%) had distant metastases, patient had liver metastasis and patient had lung metastasis Mai Duc Hung's study had a preoperative rate of distant metastasis of 5.1% 4.2 Technical characteristics of transanal total mesorectal excision 4.2.1 Technique of suturing the rectal lumen The rectum was closed a purse-string suture by the authors at least 1-2 cm below of the tumors located to be oncologically safe for distal resection We always sutured the rectal lumen at least 1cm below the tumors, and made a cut around 1cm below the suture so that the distal margins were safe for oncology 4.2.2 When to set the Genpoint Path valve In our study, for patients with tumors ≤ cm from the anal margin, they will be sutured to close the rectal lumen first, then perform dissection to create space and then place the Genpoint Path valve The rate of Genpoint Path valve placement before and after closure of the rectal lumen of the study was 73.68% and 26.32%, respectively 4.2.3 Stabilizing CO2 pressure in the transanal approach The surgical field is created from the anorectal lumen, which opens to the surrounding organization and is limited by the fixed pelvis The frequent CO2 discharge caused by smoke generated during surgery while the CO2 pump had not been able to compensate for the collapse of the surgical field was one of the difficulties of surgery Two of the most common difficulties listed by Penna were: 1) Excessive smoke obscuring visibility (accounting for 21.9%) and 2) The CO2 pressure of the surgical field was unstable (accounting for 15.6%) We maintain the CO2 pressure in the range of - 10 mmHg as appropriate 4.2.4 Sequence of dissecting phases The dissection sequence of the phases in TaTME depends on the author There are ways: first transanal or abdominal dissection or synchronous dissection of both stages by surgical teams With the goal of always achieving a safe distal margin for oncology, we chose to perform transanal approach first However, to exclude intra-abdominal metastases, all patients were examined by us with a camera before performing transanal approach Steps of transanal approach Posterior dissection Maintain the anatomical plane at the fascia surface of the fascia to avoid encroachment of the fascia or dissection too deeply with the risk of injuring the venous plexus anterior to the sacrum Studies showed no bleeding events due to injury to the venous plexus anterior to the sacrum However, if it happens, this is a very serious complication of surgery We did not experience any complications with this surgery Anterior dissection Anterior dissection in male patients at the border of the prostate gland and in women at the border with the posterior vaginal wall should identify the small vessels entering the prostate or vaginal wall (vascular and nerve bundles Walsh), with extreme caution when dissecting because it can cause damage to the urethra According to our experience, when dissection is difficult, it is advisable to 18 switch to dissection in the easy area and then gradually move back to the difficult area Penna's report on TaTME surgery had a 0.1% vaginal perforation rate Our study encountered patients with complications during anterior dissection, including: patient (1.75%) bleeding due to prostate lesions, and patient (1.75%) perforation of the posterior vaginal wall, patients who had received chemoradiotherapy before surgery Laterals dissection Attention should be paid to finding and treating the middle rectal artery (if any), paying attention to preserving the autonomic nerve branches in the lower rectum Deijen et al reported that out of 10 patients with bleeding events, there were patients bleeding from the lateral iliac wall, patient due to iliac vessel injury and patient due to damage to the left wall of the mesorectum Our study did not experience any complications when dissecting on both sides 4.2.5 Degree of transanal dissection Laparoscopy has shown that the up-to-down surgical area can reach the level of the anal levator muscle However, Penna showed that if the transabdominal area went too deep down to cm from the anal margin, the risk of obtaining poor quality mesenteric samples was six times greater In this study, we took the pouch of Douglas in front as an anatomical landmark to achieve the same surgical area For cases: large tumor, fibrous tissue adheres to the surgical area will stop before reaching the landmark with Douglas The proportions of dissection levels at Douglas level and below this level in the study were 98.25% and 1.75%, respectively Thus, compared with Penna's assessment, most of the anterior perianal dissections in our study were > 4cm, which is one of the factors that increase the probability of obtaining a hight quality of mesorectum 4.2.6 Open the pouch of Douglas Opening the pouch with Douglas into the abdomen is the final procedure of the transanal dissection, making it easier for the laparoscopic abdomen to access the surgical area from the bottom up The studies showed that the catheter should only be opened when the anal area has ended If opening the catheter too soon, it will lead to CO2 escaping into the abdomen, causing reverse compression, reducing pelvic pressure or fluid from the abdomen flowing down to the anal canal, leading to the inability to continue the surgery The rate of opening the pouch with Douglas for abdominal catheterization in our study was 44 patients (77.19%) and 13 patients without opening (22.81%) The reasons for us not opening the abdominal cavity such as when the surgical area has not reached the peritoneal fold, the tumor position in front of the peritoneal fold is large in size and there is a risk of tumor damage if trying to open 4.2.7 Specimen extraction site Depending on the horizontal size of the tumor, we will decide on the specimen extraction site, the specimen will be taken through the transanal if this size is < 4cm (due to the Gelpoint Path valve lumen placed in the anal canal having a size of 4cm) The rate of the transanal and the Pfannenstiel was 92.98% and 7.02%, respectively The rate of Specimen extraction site through transnal, Pfannenstiel and other in Burke's study were: 32%, 42% and 26%; Buchs' NCs are: 60%, 20%, and 20% 19 4.2.8 Method of anastomosis The choice of method of anastomosis depends on basic factors such as: tumor location, length of the remainder of the anorectal canal, and the surgeon's discretion An anastomosis is low (≤ cm from the anal margin), making an anastomosis by hand is convenient In this study, the anastomosis by hand and staplers were 68.42% and 31.58%, respectively, these ratios were found in some other studies such as Lacy A.M and et al were 28.6% and 71.4%, Chen C.C.and et al were 30% and 70% 4.3 Results of transanal total mesorectal excision 4.3.1 Intrao-perative results Intersphincter preserving In this study, the intersphincter preserving rates of no resection, partial resection and total resection were: 63.16%, 17.54% and 19.3%, respectively The results of sphincter preservation on defecation function will be discussed later Protective ileostomy Protective ileostomy is beneficial in the event of an anastomotic fistula, which will alleviate the condition The authors often choose to ileostomy drainage in patients who have had chemoradiotherapy before surgery or low anastomosis The study of Penna M and et al had the rate of ileostomy, ileostomy and colostomy were 83.3%; 7.3% and 9.3%, respectively In our study, ileostomy drainage depends not only on the patient's preoperative chemoradiotherapy, low anastomosis but also in patients undergoing sphincter-preserving by intersphincterectomy Prognosis of longterm recovery of sphincter function was also performed by ileostomy drainage The rate of ileostomy in this study was 50.88% Operative time The duration of surgery is an indicator that reflects the skill and experience of the surgeon, as well as the level of difficulty in each specific patient In another aspect, the time of surgery also evaluates the advantages of each surgical method Our NC results (with surgical team) had an average operative time of 150.88 minutes, equivalent to Lacy A.M.'s study was 166 minutes and shorter in studies by other authors such as Abbott S.C was 287 minutes and Burke J.P was 267 minutes We believe that The results achieved in this study are due to the fact that in the group of patients in the study there was an important favorable factor with the mean BMI (21.09 kg/m2) being lower than in the studies of the authors: Lacy (25,2 kg/m2), Abbott (27 kg/m2) and Burke (26 kg/m2) Blood loss during surgery The intraoperative blood loss volume of TaTME surgery also varied widely in the studies Simillis C has shown that the average blood loss in the studies ranged from 22 - 225 ml (0 - 600ml) In Penna's study, most of the blood loss in the studies was < 100 ml (61.2%), blood loss > 1000 ml only accounted for 1% and the cause was due to technique In this study, with an average blood loss of 83.18 ± 57.23 ml, no patient required blood transfusion during and after surgery because of intraoperative blood loss Intra-operative morbidity Velthuis's record of perineal fluid culture results in TaTME surgery had a bacterial growth rate of 39% (mainly E coli), of which 44% (1 patient had 20 anastomosis) progressed develop an anterior sacral abscess Therefore, the author recommends washing the anorectal lumen before and during surgery The types of Intra-operative morbidity related to transanal dessection were reported by a multicenter study: uncontrolled bleeding (6.9%), urethral trauma (0.7%), bladder injury (0.3%), lower hypogastric nerve rupture (0.1%), vaginal perforation (0.1%) and rectal perforation (0.3%) In our study, Intra-operative morbidity occurred in patients (3.51%), including patient with vaginal perforation and patient with bleeding due to prostate damage Both when dissecting the anterior, and we all handled it safely during surgery Conversion to open surgery The COLOR II and CLASSIC trials had a conversion rate of 16% to laparoscopic surgery and 29% higher than that of TaTME surgery in the studies by only - 3% The reason considered by most authors is that the bottom-up approach of the TaTME method can overcome the anatomical difficulties encountered by LaTME In this study, we did not record any cases requiring conversion to open surgery 4.3.2 Early results Bowel movement, using pain- killers and hospital stay time Laparoscopy has been proven by many authors to have many advantages in terms of early recovery compared with open surgery, including early bowel movement, less pain and short hospital stay Our study had mean postoperative mean time of 2.86 ± 1.17 days (1-3 days) The majority of patients only had to take pain medication for day (71.93%) and no patient had to take pain medication from the 3rd day after surgery Regarding the hospital stay for TaTME, a number of comparative studies showed no difference between the methods of open surgery, LaTME and TaTME The mean hospital stay in our study was 11.26 days Intestinal continuity was restored A total of 29 patients had ileutomy drainage, 25 patients (86.21%) had intestinal continuity was restored and 4/29 patients (13.79%) have not, the reason we have not intestinal continuity was restored is that the patients underwent endoscopic - biopsy, assessing the status of the anastomosis still inflamed, edematous Postoperative complications COLOR II study shown that the postoperative complication rate of open and laparoscopic surgery is 37% and 40%, respectively Comparative studies showed similar complication rates between methods of LaTME, open surgery and TaTME (p > 0.05) The complication rate of TaTME surgery in the studies was from 32.6% - 39% and the rate of serious complications (Clavien - Dindo III and IV) in the studies ranged from 10 to 12.5%, of which anastomotic leak was about - 8.6% This study had a complication rate of 31.58%, complications belonging to Clavien - Dindo III class had patients (15.79%), including patients with anastomotic leak and patients with anatomotic fistula and patient loss of sphincter function Surgical death