Nghiên cứu ứng dụng cắt ruột thừa nội soi qua đường âm đạo (applied research of transvaginal appendectomy technique) TT

MINISTRY OF EDUCATION MINISTRY OF HEALTH AND TRAINING HANOI MEDICAL UNIVERSITY THE THESIS IS COMPLETED AT HANOI MEDICAL UNIVERSITY Scientific advisors: Prof., Dr., TRAN BINH GIANG Prof., Dr., HA VAN QUYET DO TAT THANH RESEARCH ON THE TECHNIQUE OF TRANSVAGINAL ENDOSCOPIC APPENDECTOMY Major: Gastrointestinal surgery Code: 62720125 First opponent: Assoc Prof., Dr Nguyen Anh Tuan Second opponent: Assoc Prof., Dr Dang Viet Dung Third opponent: Dr Nguyen Manh Tri This thesis is defended at University Thesis Examination Council, held at Hanoi Medical University, At … …… hour … minute on … … … 2021 SUMMARY OF DOCTOR OF MEDICINE THESIS The thesis may be read at: - National Library of Vietnam - Library of Hanoi Medical University HANOI - 2021 LIST OF AUTHOR’S PUBLICATIONS RELATED TO THE THESIS A case report of transvaginal endoscopic appendectomy: The difficulties and the applicability Initial results of transvaginal laparoscopic appendicectomy The results of laparoscopic appendectomy through vaginal route Applying experimental laparoscopic appendectomy through vaginal route on pig 1 INTRODUCTION Necessity of the thesis Natural orifice transluminal endoscopic surgery is a intervention surgical technique through natural orifices (for example: Digestive tract, vaginal tract, etc.) In Viet Nam, endoscopic surgery has been performed since 1992 - 1993 and has been developing quickly since then However, because researching on and applying natural orifice transluminal endoscopic surgery still meet lots of difficulties in terms of equipment, costs, attitudes of patients, etc so far there has been no research on this field being conducted New contributions of the thesis: This is the first study in Viet Nam on researching on and applying transvaginal appendectomy by animal testing and on human Theoretical and practical implications of the thesis Research results shall be the background for the application of natural orifice transluminal endoscopic surgery on treating abdominal diseases Also, research results can be applied on training medical specialists in the future Structure of thesis The thesis comprises 138 pages, as follows: Introduction (2 pages), Overview (45 pages), subjects and methods of research (16 pages), results (30 pages), discussion (41 pages), conclusion (3 pages), and recommendations (1 page) The thesis has 45 tables, 22 images, charts, 126 references including 10 Vietnamese, 111 English, German, Spanish and Chinese CHAPTER OVERVIEW 1.1 ANATOMICAL FEATURE OF APPENDIX AND VAGINA 1.1.1 Anatomical features of appendix Appendix is a worm-shaped or tube-shaped organ, with an average length of - cm - Appendicular artery: Is a branch of ileocolic artery - Appendicular vein: Accompanies the appendicular artery, drains blood into ileocolic vein, through superior mesenteric vein, and then to portal vein - Nerve supply: Nerve supply in appendix is part of autonomic nervous system In appendicular wall there are nerves and Auerbach's and Meisner's plexuses 2 1.1.2 Anatomical features of vagina Vagina is a canal that extends from the cervix to the vulva, being about cm long, behind the bladder and urethra and in front of the rectum 1.1.2.1 Gross anatomy and associations of vagina * Anterior side: Related to urethra, bladder and the end section of ureter * Posterior side: Related to pouch of Douglas, pelvic diaphragm, rectum * Lateral side: Related to broad ligament, levator ani, pubococcygeus muscle, vestibular bulb and Bartholin's glands 1.1.2.3 Blood and nerve supply - Vaginal artery emerges from uterine artery or from middle rectal artery or directly from internal iliac artery - Vaginal veins form the vaginal venous plexus, connecting to uterine venous plexus above, and vesical venous plexus to the front, and drain into the internal iliac veins - Lymph drains into the uterine artery or vaginal arteries and to inguinal lymph nodes Nerve supply is from hypogastric plexus 1.2 CLINICAL AND SUBCLINICAL FEATURES OF APPENDICITIS 1.2.1 Clinical features of acute appendicitis 1.2.1.1 Functional symptoms: Abdominal pain, vomiting and nausea: Often occur in children Other symptoms: Loss of appetite, obstipation, constipation or diarrhea, etc Systemic symptom: Fever of about 38oC 1.2.1.2 Physical symptoms Right lower quadrant abdominal tenderness, pain in the right lower quadrant, skin hypersensitive in right lower quadrant Blumberg's sign, Rovsing's sign Rectal examination or vaginal examination may show pain in right wall of rectum or in the right of vaginal fornix 1.2.2 Subclinical symptom - Blood count: white blood cell count increases to more than 10 G/l - Abdominal ultrasound: Sensitivity, specificity and accuracy are more than 90% - CT scan (after contrast material administration): dilated appendix with (diameter of more than mm) wall thickening (more than mm) and fluid inside 1.3 NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY Natural orifice transluminal endoscopic surgery is an endoscopic approach in which surgical intervention is performed through natural orifice (mouth, vagina, urethra and anus) and then through an opening in the wall of stomach, vagina, bladder or colon Natural orifice transluminal endoscopic surgery has advantages of avoiding scars, reducing surgical pain and helping patients recover quicker than other traditional endoscopic surgery and open surgery Combination of transvaginal endoscopy in lesser pelvis through pouch of Douglas with cervical endoscopy and ovarian endoscopy with injection of methylene blue This technique does not require sophisticated equipment and examination of the whole peritoneal cavity 1.4 PHYSICAL IMPACTS OF NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY Natural orifice transluminal endoscopic surgery uses natural orifice to reach peritoneal cavity, thoracic cavity with an aim to minimize damage caused by surgery Comparing with open surgery and laparoscopic surgery, natural orifice transluminal endoscopic surgery is expected to bring about outstanding advantages, such as reducing postoperative pains, reducing risks of complications related to surgical incisions, causing less adhesion, and allowing faster recovery due to less inflammatory response, and especially guaranteeing better cosmetic features 1.5 METHODS FOR TREATING APPENDICITIS When there is a confirmed diagnostic of acute appendicitis, the only method for treatment is emergency appendectomy as soon as possible; the later the appendectomy is performed, the higher the risk of complication is Removal of the appendix can be done by traditional open surgery or by endoscopic surgery 1.6 LITERATURE RELATED TO TRANSVAGINAL APPENDECTOMY 1.6.1 Techniques of transvaginal appendectomy There have been a number of procedures, techniques for perform this surgery, which can be sorted into main types: Pure natural orifice translumenal endoscopic surgery (pure NOTES) and combined laparoscopic and NOTES techniques (hybrid NOTES) Transvaginal appendectomy has a number of special advantages, for example there is no need to use soft or flexible devices, as this technique allows use of rigid endoscopic devices, port for 1-port endoscopic devices, and handsewn closure techniques of pure transvaginal appendectomy: * Technique of pure transvaginal appendectomy using flexible endoscopic system with specialized devices * Technique of pure transvaginal appendectomy using conventional endoscopic devices 4 1.2.2 Literature related to transvaginal appendectomy in the world and in Viet Nam 1.2.2.1 In the world Since 2000, transvaginal appendectomy has been developing In 2001, Tsin D and colleagues published initial results of transvaginal appendectomy in patients So far, a number of researches have shown natural orifice translumenal endoscopic appendectomy is a safe technique, with transvaginal appendectomy being more advantageous 1.2.2.2 In Viet Nam Currently in Viet Nam there is no research on application of natural orifice translumenal endoscopic appendectomy Application of natural orifice translumenal endoscopic surgery requires high expenses and the combination of surgery and flexible endoscopy, which most of medical facilities in Viet Nam cannot afford With current conditions of funding and equipment, the only applicable technique is transvaginal appendectomy using conventional endoscopic devices - Sample size of clinical research: All of female patients with appendicitis meeting inclusion criteria being treated at Viet Duc University Hospital in the period of years (36 months) from 1/9/2011 to 30/9/2014 2.2.2 Method of information collection 2.2.2.1 Collection of data from clinical and subclinical examinations - Subjects of research being patients having clinical signs of appendicitis are selected according to inclusion criteria, and data are collected in following steps: history taking, clinical examination and tests, plain abdominal radiography, abdominal ultrasonography, etc - If the patient has indication for surgery: + Conditions of the patient is compared with inclusion and exclusion criteria + Doctor explains endoscopic appendectomy and the new technique of transvaginal appendectomy for the patient to select - We collect data about sexual functions using female sexual function index questionnaire for patients agreed to undergo transvaginal appendectomy 2.2.2.2 Collection of data during surgery - Operating time - Lesions found during surgery - Techniques applied during surgery - Intraoperative complications 2.2.2.3 Collection of data in postoperative period - Data of progression of treatment, including pain, time to intestinal flow; time to bowel movement, postoperative complications are collected until the patient is discharged - After the patient is discharged, we collect data of pain, conditions of bowel movement, postoperative complication and sexual functions in months 2.2.3 Surgical procedure of transvaginal appendectomy for the human subjects of research 2.2.3.1 Preparation of equipment 2.2.3.2 Introduction of anesthesia 2.2.3.3 Position of patient: The patient is placed in lithotomy position, head lowered and leaned to the left or right depending on surgical requirement Urinary catheter and gastric catheter are placed 2.2.3.4 Location of operating staff: The operating surgeon and the assistant stand between the patient’s leg The endoscopic screen is positioned above patient’s head, perpendicular with view direction of the surgeon (in OR1 endoscopy room) or to the left of the patient CHAPTER SUBJECTS AND METHODS OF RESEARCH 2.1 SUBJECTS OF RESEARCH 2.1.1 Animal experimentation 30 pigs for experimental surgery white purebred female pigs 2.1.2 Clinical study Female patients, aged from 18 to 60, with a history of vaginal delivery, having been examined with indications for endoscopic appendectomy at Viet Duc University Hospital * Inclusion criteria: - Being female patients aged from 18 to 60 years old and diagnosed with appendicitis - Having preoperative diagnosis of acute appendicitis, chronic appendicitis, of having diagnosed with appendicitis, appendicular abscess, appendicular phlegmon > months in prior and being clinically stabilized - Having indication for endoscopic appendectomy - Having a history of vaginal delivery 2.2 METHODS OF RESEARCH 2.2.1 Design and sample size of the research * Design of the research: Analytical descriptive prospective research * Sample size: - Sample size of animal experimentation: Minimum sample size of 30 pigs 6 2.2.3.5 Trocar site: Trocar is often placed through vaginal canal In difficult cases which high risk of damage to organs is expected, 01 trocar may be placed above navel for observation and evaluation Depending on specific case, a trocar is placed in vaginal canal, or the case is converted to conventional laparoscopy The next step is gas pumping and the surgeon use camera to view and assess abdominal cavity to decide on surgical techniques 2.2.3.6 Surgical procedure of pure transvaginal appendectomy - Disinfecting vagina with Betadine solution - Using speculum to expose cervix - Grasping the cervix and pulling upward and outward to expose the posterior vaginal fornix - Incising the vagina fornix to enter abdominal cavity - Introducing trocar into abdominal cavity through the incision - Introducing camera into abdominal cavity - Viewing abdominal cavity and examining the operative field: Thoroughly examining abdominal cavity, especially the right lower quadrant to find whether there is fluid, pus or pseudomembrance and to examine conditions of the appendix, cecum and ileal loop - Dissection of the appendix: Using a grasper from the right trocar to elevate the appendix superiorly and expose the mesoappendix Ligating vascular vessels and divide the mesoappendix to the base of appendix Ligating the base of the appendix with an intracorporeal endoscopic knotting or using hemolock clip - After dissecting the appendix, re-inspecting the base of the appendix, mesentery, then cleaning and draining the abdominal cavity Removing the appendix from the abdomen, and closing vaginal incision with vicryl-0 suture 2.2.4 Assessment of surgical outcomes 2.2.4.1 Data collected during surgery - Time of surgery - Placement of the first trocar, complication of trocar placement - Number of trocar - Volume of fluid drained from abdominal cavity, color and turbidity of fluid - Condition of appendix, cecum, and ileal loops - Placement of assisting trocar is the technique requiring an additional trocar on navel - Reason for assisting endoscopy - Reason for and rate of conversion to conventional laparoscopy - Difficulties and technical precautions as well as change in surgical technique of each surgery 2.2.4.2 Evaluation of early result - Location of pain - Days of using analgesic - Degree of pain - Quantity of antibiotics and infusion fluid to be used - Time to recovery of intestinal peristalsis - Length of stay - Condition of surgical incision - Early postoperative complications: Early bowel obstruction, peritonitis, digestive leakage - Prolonged paralytic ileus - Other complications 2.2.4.3 Evaluation of remote result After being discharged from hospital, the patients were scheduled for regular examinations, received phone calls or questionnaires in month, months, months asking for: - Whether postoperative pain occurred or not, and when the pain ended - Condition of bowel movement - Condition of surgical incision infection - Remote postoperative complications: Residual abscess, postoperative bowel obstruction, etc - Whether the patients were satisfied with the performed technique - For patients underwent transvaginal appendectomy, information about conditions of sexual intercourse were collected using the questionnaire used before surgery, and this collection was conducted in the third month after surgery 2.2.5 Method of data processing: Using SPSS 22.0 CHAPTER RESULTS OF RESEARCH 3.1 RESULT OF ANIMAL EXPERIMENTATION 3.1.1 Trocar site Table 3.1 Trocar site on animal subjects Group Trocar site Number Percentage of pigs (%) 01 10mm trocar placed through navel Group for visualization; 6,7 02 transvaginal devices for operating 01 trocar for visualization and 02 Group devices introduced the vaginal canal 18 60 (in sites) Group 01 trocar through navel, 02 trocar in 10 33,3 vagina Total 30 100,0 The research team considers that for pigs of average weight of 30kg and not having given birth, their vagina is too small for performing pure transvaginal appendectomy, and also the research team sees that hybrid transvaginal appendectomy is possible 3.1.2 - Conditions of abdominal cavity Most of the pigs had normal conditions of abdominal cavity (93,3%) 2/30 (6,7%) cases had previous abdominal adhesion 3.1.3 Operating time Table 3.5 Operation time of animal experimentation Group Transvaginal Duration (minutes) appendectomy Mean Shortest - Longest Group Hybrid (1) 27,5 25- 30 Group Pure (2) 58,6 40- 160 Group Hybrid (3) 38,4 30- 60 p p1,3- 20,05) In addition, most of the patients did not have gynecological diseases or other diseases related to transvaginal appendectomy A number of patients had history of adnexitis (12,5%), or recently had abortion (8,3%), miscarriage (8,3%) 3.2.2 Clinical features Mean temperature of appendicitis patients was 37,27 ± 0,55 oC Most of the patients had pain in the right lower quadrant (87,5%), and hypogastric pain (12,5%) Most of the patients had infection (97,4%) and abdominal tenderness (+) (95,4%) 3.2.3 Subclinical characteristics Mean white blood count of the patients was 10,95 ± 3,41 G/l (from 4,57 G/l to 17,50 G/l) Table 3.17 Features of ultrasound and abdominal CT scan Of appendicitis patients Ultrasound and Transvaginal Conventional Total abdominal CT appendectomy endoscopic (n= 152) scan (n= 24) surgery (n= 128) Number Rate Number Rate Number Rate of (%) of (%) of (%) patients patients patients Appendicitis, without 13 54,2 65 50,8 78 51,3 abdominal fluid Appendicitis, with abdominal 11 45,8 63 49,2 74 48,7 fluid p> 0,05 showing abdominal fluid in the group underwent transvaginal appendectomy (45,8%) was not different from that of the group underwent conventional laparoscopy (49,2%), p>0,05 3.2.4 Technical features of transvaginal appendectomy Most of the cases had the first trocar introduced through vagina (54,1%), of which: Through posterior wall: 45,8% and through right wall: 8,3% (29,2%) cases had trocar introduced through navel and (16,7%) case had vaginal adhesion and must be converted to conventional laparoscopy Table 3.19 Conversion of surgical method Results in Table 3.17 show that: Ultrasound and abdominal CT scan show that 51,3% of the patients had images of appendicitis without abdominal fluid, and 48,7% have images of appendicitis with abdominal fluid The rate of patients having ultrasound and abdominal CT scan Surgical method Transvaginal appendectomy Conversion of transvaginal appendectomy to conventional laparoscopy Conventional endoscopic surgery Conversion of endoscopic surgery to open surgery Transvaginal appendectomy (n= 24) Number Rate of (%) patients 20 83,3 Conventional laparoscopy (n= 128) Number Rate of (%) patients 0 16,7 0 0 123 96,1 0 3,9 Results in Table 3.19 show that: In the group underwent transvaginal appendectomy, 2/24 (16,7%) cases were converted to conventional laparoscopy due to adhesion preventing placement of trocar In the group underwent conventional laparoscopy, 5/128 (3,9%) cases were converted to open surgery As such, the actual number of patients underwent transvaginal appendectomy was 20 and conventional laparoscopy 127 In the group underwent transvaginal appendectomy, most of the patient underwent pure transvaginal appendectomy (65%) and 7/20 (35,0%) underwent transvaginal appendectomy assisted with abdominal trocar In the group underwent transvaginal appendectomy, most of the base of mesoappendix was treated by electrocautery (80,8%); and 4/20 (20%) by bipolar electrocautery In the group underwent transvaginal appendectomy, most of the base of appendix was treated by extracorporeal knotting (85,0%), and 3/20 (15,0%) by hemolock clip 12 13 3.2.5 Features of appendicitis determined during operation Table 3.23 Features of appendicitis determined during operation Features of appendicitis Congestive Purulent inflammation, necrosis Abscess, perforation, wrapped by omentum and cecum Transvaginal endoscopic surgery (n= 20) Conventional laparoscopy (n= 127) Open surgery (n= 5) Total (n= 152) 65,0 10,0 96 75,6 p> 0,05 2,4 Group 60,0 20,0 112 Rate (%) 22,4 73,7 3,9 152 100,0 The table 3.23 shows that during operation, most of the appendixes had purulent inflammation, necrosis (73,7%) The number of cases had congestive inflammation accounted for a lower rate (22,4%) and only 3,9% of the case had appendicular abscess, or appendicular perforation wrapped by cecum and omentum The rate of patients having purulent inflammation, necrosis in the group underwent transvaginal appendectomy (65,0%) was not different from that of the group underwent conventional laparoscopy (75,6%), p>0,05 Most of the cases were exudate (86,8%) 21/152 (13,2%) had turbid fluid and pseudomembrance The rate of turbid fluid of the group converted to open surgery (80,0%) was higher than that of the group underwent conventional laparoscopy (9,4%) and the group underwent transvaginal appendectomy (20,0%), and this difference is statistically significant, p 0,05 Total (n= 152) 4,52 ± 1,63 (1- 12) Results in Table 3.36 show that: Length of stay of the group underwent transvaginal appendectomy (4,15 ± 2,27 days) was shorter than that of the group underwent conventional laparoscopy (4,58 ± 1,51 days) and conversion to open surgery (4,60 ± 1,81 days), but this difference is not statistically significant (p>0,05) 3.2.9 Post-operative remote result Female sexual function index of the group underwent transvaginal appendectomy before and months after surgery changed statistical insignificantly (15,80 ± 2,60 compared with 15,65 ± 2,70, p>0,05) CHAPTER DISCUSSIONS In this research, we performed transvaginal appendectomy using conventional endoscopic devices Besides the advantage of not requiring expensive equipment, high safety of high-tech technique, the major disadvantage of this technique is that this can only be indicated for female patients meeting strict criteria of gynecological history as well as research ethics Therefore we only performed this technique on female patients aged from 18 to 60, married and with consent of at least both husband and wife to voluntarily join the research population 18 19 4.2.3 Contraindication for transvaginal appendectomy The authors agree that: Absolute and relative contraindications to transvaginal appendectomy include the following: - Evidence of perforation - Pregnancy, - Recent deliveries (within the preceding months), - ASA classification or 4, - History of pelvic inflammatory disease, - History of endometriosis, - History of inflammatory bowel disease, and - History of retroflexed uterus 4.3 ASSESSMENT OF POSTOPERATIVE EARLY OUTCOMES OF TRANSVAGINAL APPENDECTOMY 4.3.1 Conversion of surgical method Our research shows that in the group underwent transvaginal appendectomy, 2/24 (16,7%) cases were converted to conventional laparoscopy due to adhesion preventing placement of trocar In the group underwent conventional laparoscopy, 5/128 (3,9%) cases were converted to open surgery As such, the actual number of patients underwent transvaginal appendectomy was 20 and conventional laparoscopy 127 The rate of conversion to conventional laparoscopy of our research is similar to that of the research of Roberts K E and colleagues (2012) which compared results of pure transvaginal appendectomy (18 patients) with that of traditional 3-port laparoscopic appendectomy (22 patients) and found that one conversion in the pure transvaginal appendectomy group to a traditional 3-port laparoscopic appendectomy was necessary because of inability to maintain adequate pneumoperitoneum Bulian D R and colleagues (2017) analyzed 217 cases of transvaginal appendectomy and transgastric appendectomy and found that the conversion to laparotomy rate of the group having transvaginal appendectomy (0%) is lower than that of the groups having transgastric appendectomy (5,6%), p