Improved Outcomes in Colon and Rectal Surgery part 25 pdf

 improved outcomes in colon and rectal surgery will result in urge incontinence as well with stool clustering and increased frequency. Secondly, the history should identify concomi- tant symptoms, such as urinary incontinence and pelvic organ pro- lapse since FI is frequently only part of a more general pelvic floor dysfunction. Thirdly, questions should elicit underlying risk factors, particularly those that are readily corrected (Table 22.1). Emphasis must be given to a detailed obstetric history to identify surrogate markers of a traumatic childbirth (instrumental delivery, prolonged second stage of labor, birth weight greater than 4 kg, episiotomy) (8) and to evaluate the presence of FI symptoms in the postpartum period. A careful assessment of stool consistency and defecation habits will help determine the potential benefits of a bowel regulat- ing treatment. Finally, a detailed history of FI will guide selection of appropriate investigations. Physical examination should identify possible causes, effects and coexisting conditions of FI. Perineal scarring, diminished perineal body, or palpable sphincter defects will suggest obstet- ric trauma. A patulous anus is a sign of sphincter denervation. Dermatitis and excoriation result from prolonged exposure to feces and poor hygiene. Furthermore the clinician should actively look for any anorectal conditions causing “pseudo-incontinence” such as rectal prolapse or prolapsing hemorrhoids, skin tags, mucosal ectropion, or fistula in-ano. Digital rectal examination provides gross information on sphincter bulk, anal canal tone, anal stenosis, and presence of masses. A vaginal exam is essential to assess for coexisting conditions such as rectocele, enterocele, uterine or vaginal apex prolapse and cystocele. Additional studies The aim of additional studies is to identify the cause of FI and risk factors amenable to treatment. Endoscopic examination, at least a flexible sigmoidoscopy if not a full colonoscopy, should be performed to rule out conditions that may contribute to FI such as polyps, malignant lesions, or inflammatory bowel disease. A variety of anorectal physiology tests (ARP) are available to further clarify the etiology of FI. Sphincter anatomy can be assessed by endoanal ultrasound or MRI; resting and squeeze anal canal pressures can be measured by manometry; anorectal sensation and reflexes (minimal volume to elicit sensation, maxi- mal tolerated volume, presence of rectoanal inhibitory reflex) can be estimated by balloon inflation manometry or with techniques that measure thermal change sensitivity or mucosal electrosen- sitivity; integrity of sphincter innervation can be evaluated by pudendal nerve terminal motor latency and electromyography; defecation dynamics can be assessed by barium cinedefecogra- phy, balloon expulsion tests, and more recently by dynamic MRI. However, the need for ARP testing outside of research cent- ers is still debated (15–17) for several reasons. There is relative absence of standardization of test techniques and norm values established from large cohorts of healthy individuals. Few stud- ies have shown clear correlations between baseline ARP and treatment outcome. Studies evaluating the clinical utility of ARP have all too often included only small numbers of patients and contained important design flaws. Having said that, in these studies ARP testing appeared to improve the understanding of etiology and change treatment strategy of FI in approximately 15%.(18–20) Most changes in treatment strategy were due to more accurate assessment of sphincter defects with endoanal ultrasound (EAUS). Since the decision between medical or sur- gical management (sphincter repair) of FI is largely based on the extent of sphincter injury, imaging of the sphincter makes sense. Both EAUS and MRI (with endorectal coil) appear to be highly accurate in identifying sphincter defects (21), especially of the distal part of the anal canal.(22) EAUS has the advantage of being inexpensive and readily available. Three-dimensional EAUS (Figure 22.1a and 22.1b) and transperineal ultrasound may further increase accuracy.(23, 24) MRI depicts the external Figures 22.1a and 22.1b (a)EAUS image of a normal anal canal with complete internal sphincter (IS) hypoechogenic ring and external sphincter (ES) hyperechogenic ring. (b)EAUS image of anal canal with a wide internal (IS) and external sphincter (ES) defect. Note the thickening and retraction of the internal sphincter and the anterior scar (S) replacing the external sphincter. (a) (b) s IS ES ES IS  surgical treatment of fecal incontinence sphincter clearly because of the contrast between fat and striated muscle and accurately visualizes external sphincter atrophy. External sphincter atrophy can also be accurately diagnosed with 3D-EAS (25); its significance is not fully understood but it may adversely affect outcome after sphincterplasty.(26) The value of sphincter imaging has also been demonstrated in men with FI. The presence of a sphincter defect –an internal sphincter defect secondary to anal surgery in the vast majority of men – was a clear predictor of failure of conservative management.(27) In conclusion, the assessment of a patient with FI must include a directed, detailed history and examination. After excluding cases of “pseudo-incontinence” or minor seepage additional work-up must include endoscopy and sphincter imaging, especially if treat- ment with sphincteroplasty is considered. Defecography is helpful to confirm suspected rectal procidentia. The utility of further ARP studies will depend on local availability and expertise. TREATMENT Medical therapy Initial treatment of FI should be conservative even if there is little evi- dence to guide clinicians in the selection of drug therapies.(28) The main targets of medical treatment of FI are intestinal transit and stool consistency. A thorough work-up is mandatory in patients with FI related to chronic diarrhea to identify and treat the underlying cause of diarrhea. Dietary changes and prescription of either fiber supple- mentation or fiber restriction must be individualized to each patient as the change in bowel transit can be very variable.(29) In a placebo controlled trial, psyllium and gum arabic, two natural soluble fibers, were shown to reduce by 50% the proportion of incontinent stools in 39 patients with FI of loose or liquid stools.(30) Antidiarrheal medi- cation (loperamide, diphenoxylate plus atropine, bile-acid binders, codeine) is the next step in medical management of FI. Loperamide has been shown to be more effective than diphenoxylate plus atropine, and have fewer side effects than both diphenoxylate plus atropine and codeine.(31) In addition to its effect on intestinal motility, loperamide may improve sphincter tone and rectal sensation.(32) In an open label trial in 18 patients with idiopathic FI, amitriptyline, a tricyclic antide- pressant agent, was shown to improve FI scores in 89% of patients after 4 weeks of treatment; the proposed mechanism is a decrease in rectal motor complexes and stool frequency.(33) Further studies are needed to evaluate the true efficacy of this drug. A different approach of medical treatment is to enhance anal sphincter function by application of topical agents, such as phenylephrine gel, an α1-adrenergic agonist. Three small dou- ble blind placebo trials from the St. Mark’s hospital in the UK showed significant improvement in sphincter tone (34) and FI symptoms in half of ileal pouch patients (35) and in one third of FI patients with anatomically intact sphincters.(36) Conversely, Park et al. (37) in a double blind trial on 35 patients with FI after low anterior resection found no improvement in FI or quality of life scores with 30% topical phenylephrine compared to placebo. Limited efficacy combined with frequent allergic reactions, limits wider acceptance of this treatment. Constipation and impaction can lead to overflow incontinence. Such patients will benefit from routine tap-water enemas or laxa- tives to empty the rectum regularly. Patients with postdefecation seepage may also benefit from routine enemas as well as appli- cation of cotton wicks at the anus and barrier creams to avoid excoriation and pruritus. Anal plugs for the management of FI is a different approach that appears intuitive to many patients. A recent Cochrane review of pub- lished randomized trials suggested that anal plugs seem to be difficult to tolerate but if they are tolerated, they can be a useful tool in FI pre- vention either as substitute or adjuvant treatment option.(38) Anal plug models exist in a variety of forms, sizes, material, and function. Devices with intrarectal sensors alerting the patient of an imminent bowel movement with a beep have also been described.(39, 40) Biofeedback The goal of biofeedback is to improve external sphincter contrac- tion (strength and duration) in response to rectal distention by providing the patient with feedback information on perform- ance and progress. In general, three different protocols are used: (1) coordination training, which teaches patients to contract their external sphincter muscle in response to rectal distention counteracting the reflex internal sphincter relaxation; (2) sen- sory training, which teaches patients to recognize progressively smaller volumes of rectal distention enabling them to contract the sphincter in time; and (3) strength training, which teaches patients to isolate and exercise their sphincter muscle without using rectal distention. In most centers, either manometry equip- ment or an EMG probe is used to provide “feedback” information to patients. The three training methods are sometimes combined; the length and number of sessions varies widely. Biofeedback is widely used and often included as first line option in treatment algorithms for FI. No obvious clinical or physiologic predictors of success have been identified. Patient age, etiology of FI, duration, and severity of symptoms do not appear to predict outcome; biofeedback has been used successfully in a variety of situations including presence of external sphincter defects (41) or in patients with poor functional outcome after sphincteroplasty for obstetric injury.(42) A systematic review on biofeedback through 2000 (43) found 46 original studies, only 8 of which employed some form of control arm. All but one study (44), which included patients with neurogenic FI, reported improvement of symptoms in a range of 53–100% of patients. Overall, 617 of 861 (72%) reported to be cured or improved. The same author performed a Cochrane review (45), including only randomized or quasi randomized trials and concluded that the cur- rent literature provides no evidence that biofeedback or anal sphinc- ter and pelvic floor exercises improve outcome compared to other conservative management methods. Training to enhance rectal discrimination of sensation seemed to be helpful in reducing FI in one short follow-up randomized study.(46) In absence of high level evidence, interpreting the literature on biofeedback is problematic. Some patients seem to benefit and there has been no morbidity reported. High motivation both from the patient’s and therapist’s side are crucial prerequisites for a successful outcome. Sphincteroplasty Anal sphincteroplasty is an appropriate therapy for patients with significant FI, unresponsive to medical therapy and a documented anal sphincter defect.  improved outcomes in colon and rectal surgery Overlapping sphincteroplasty is usually performed under general anesthesia, in the prone jack knife position after prior mechanical bowel preparation and prophylactic antibiotics. A curvilinear incision is made in the perineal skin closer to the vagi- nal introitus than the anus to preserve tissue on the anal side. A Lone Star® retractor is used for exposure and a needle tip electro- cautery is preferred for more precise dissection with less char. The external sphincter, en bloc with the internal sphincter and anterior scar tissue is mobilized and dissected free from the skin and ischiorectal fat laterally, from the posterior vaginal wall ante- riorly and from the anoderm and rectal wall posteriorly. Careful dissection, occasionally aided by inserting a finger in the vaginal or rectal side, avoids buttonholing, especially on the rectal side. Any injured venous sinuses on the posterior vaginal wall should be suture ligated to avoid delayed hemorrhage. Care must be taken with the posterolateral portions of the dissection to avoid injury to branches of the pudendal nerve. Dissection in the mid- line continues until soft, pliable tissue is reached on both the vaginal and rectal sides and laterally until the two ends of the external sphincter can be overlapped several centimeters without tension. If the midline tissue is entirely scar tissue, it is divided to perform an overlapping repair. If muscle is encountered in the midline it is left intact and an imbricating repair rather than over- lapping repair is performed. The overlapping repair is done with absorbable 2–0 monofilament mattress sutures creating a snug anal opening without excess tension on the mobilized tissue. The wound is closed in a vertical or “T” fashion to decrease tension on the skin. The center of the incision is left open and a short ¼ inch Penrose or closed suction drain is placed through the opening to facilitate drainage. The drain is removed before the patient’s discharge. Vaginal packing may be placed to help with hemostasis and if used is typically removed the next day. If planned, anterior levatoroplasty is performed before the overlap. Proponents argue that the levatoroplasty adds essential bulk to the perineal body and lengthens the anal canal. Opponents believe that a levatoroplasty increases the incidence of postoperative dyspaurenia. Diversion of the fecal stream did not improve healing or functional results of the repair in a randomized trial.(47) As with any perineal wound, healing after overlapping sphinc- teroplasty is slow with frequent separation of the skin edges. Postoperative care includes the avoidance of impaction with the use of bulk agents and tap water enemas and protection of the surrounding skin with barrier ointments. Vaginal tampons and intercourse are proscribed for 6 weeks. One variation is the approximation of the ends of the sphincter muscle rather than overlapping them. This technique is particu- larly appropriate when a portion of the muscle is intact. In a ran- domized study by Tjandra et al. (48) of 23 women with anterior sphincter defects on EAUS, no functional difference was found between patients repaired with the approximation technique and those undergoing an overlapping repair. Functional results after overlapping sphincteroplasty are good or excellent approximately in two-thirds of patients in studies with a follow-up under 4 years (Table 22.2a) and approximately in one half of patients in studies with a longer follow-up (Table 22.2b). Bravo-Gutierrez et al. reviewed functional outcome a median of 10 years after sphincteroplasty in 130 women and found that 58% reported some incontinence of solid stool compared to 36% at a 3 years follow-up.(49) Similarly, Barisic et al. found increased failure rates with time as poor results were reported by 39% at 80 months compared to 9% at 3 months.(50) Malouf et al. reviewed the results of sphincter repair in 46 patients a median (range) of 77 (60–96) months.(51) Excluding 8 immediate failures 85% of the others reported improvement at 15 months but only 50% at 77 months. Only 4 patients were completely continent of stool but the median subjective rating of satisfaction with the Table 22.2a Functional results of sphincteroplasty – short and midterm follow-up. Months Follow-up Median Excellent Author Year n (range) or Good Fair Poor Nikiteas (106) 1996 42 38 (12–66) 60% 17% 23% Oliveira (107) 1996 55 29* 71% 9% 20% Young (108) 1998 57 18 86% — 14% Gilliland (109) 1998 77 24 (2–96) 55% 14% 31% Karoui (110) 2000 86 40 a 81% — 19% Buie (111) 2001 158 43 a (6–120) 62% 26% 12% Morren (112) 2001 55 40 (5–137) 56% 24% 20% Pinta (113) 2003 39 22 (2–99) 31% 38% 31% Evans (114) 2006 66 45* 77% — — a. Mean. Table 22.2b Functional results of sphincteroplasty – long term follow-up. Author Year n included/n initial Years Follow-up Median (range) Excellent or Good Fair Poor Londono-Schimmer (115) 1994 94/128 4.9 (1–8.2) 50% 25% 25% Malouf (51) 2000 46/55 6.4 (5–8) 50% 9% 41% Halverson (116) 2002 49/71 5.3 (2–11.8) 49% — 51% Zorcolo (117) 2005 62/93 5.8 a (2–9.3) 54% 16% 30% Barisic (50) 2006 56/65 6.7 a 48% 13% 39% Bravo-Gutierrez (49) 2004 130/182 10 (7–16) 41% — 57% Maleskar (52) 2007 64/72 at 7 62% 24% 15% Grey (118) 2007 47/85 5–12 60% 36% 4% a. Mean.  surgical treatment of fecal incontinence long term results was 8 out of 10. Other studies document more optimistic results. Maleskar et al. reported on 64 of 72 patients responding to a questionnaire after a median of 7 years.(52) The median CCF-FI score dropped from 16 preoperatively to 5 at 12 months and to 7 at a median follow-up of 7 years. Ninety five percent of patients were satisfied with the results and 62% were fully continent or incontinent to gas only. Interestingly, Vaizey et al. found no difference in incontinence scores, patient rating of improvement or satisfaction between the findings at 20 months and 60 months in a group of patients who underwent a repeat sphincter repair following a failed repair.(53) If the initial repair fails and a persistent defect is demon- strated by ultrasound, repeat sphincteroplasty can still provide satisfactory results (54, 55) even with long-term follow-up.(53) Breakdown of the wrap is not the only cause of failure. Progressive neuropathy and the aging process in general are thought to con- tribute to some deterioration of symptoms over time. Patients with poor results may be candidates for biofeedback, artificial bowel sphincter, or sacral nerve stimulation. The role of sphincteroplasty in patients with incontinence and sphincter defects is evolving with the addition of new modali- ties of therapy. Further research is necessary to determine which patients are appropriate candidates and whether adjunct therapies such as biofeedback or sacral nerve stimulation would improve the functional results. Artificial Bowel Sphincter The artificial bowel sphincter (ABS) is a treatment modality for urinary incontinence which was adapted for FI. In 1996, the man- ufacturing company (American Medical Systems, Minnetonka, MN, USA) adapted the original device for its use in FI as the Acticon TM Neosphincter device. Although other models have been recently developed (56, 57), this device is the most widely employed and reported in the literature. The ABS consists of three components: an inflatable cuff, placed around the deficient sphincter, a pressure-regulating bal- loon placed in the retropubic space, and a control pump placed in the scrotum or labia. The three components and the connecting tubing are filled with saline. In the neutral state, the fluid fills the cuff occluding the anal canal. When the patient desires to defecate, he empties the cuff by manually compressing the pump, which pushes the fluid into the pressure regulating balloon. The cuff refills spontaneously in approximately 45 seconds. The ABS is an invasive procedure with significant morbidity. Candidates include patients who have failed all medical treatment and are not candidates for a sphincter repair. Sufficient perineal tissue without excessive scarring or prior radiation and a normal rectal reservoir are required to minimize risk for late erosion and dysfunction.(58) Mundy et al. (59) performed a systematic review of the litera- ture published through 2002 on safety and effectiveness of ABS in FI. They included 13 case series involving 1 to 112 patients with a mean follow-up time of up to 60 months. No study included a control group or reported intention to treat results prevent- ing judgment of the true effectiveness of ABS. Approximately a third to half of patients needed surgical revision of the ABS and one quarter required explantation, most commonly because of infection or erosion. Wound healing problems, material breakage or migration, fecal impaction, chronic pain, and dissatisfaction also occurred. In patients with successful implantation, all stud- ies reported clinically significant improvements in FI severity and quality of life. O’Brien et al. (60) performed a randomized trial on 14 patients with severe FI comparing ABS to optimal medical therapy. In the ABS group one out of seven patients had explantation of the device after failed wound healing and two had prolonged hospitalization for repeated fecal impaction or wound healing problems. At 6 months, the Cleveland Continence Score showed a 75% improvement in the ABS group with significantly better quality of life scores. No significant changes were observed in the medical treatment group. Long term follow-up studies on ABS report higher rates of reintervention and explantation with a functional ABS (61–63) remaining in approximately 50 to 60% of patients. Patients who retained their ABS seemed to have sustained improvement of FI and quality of life over time (63) but a significant number expe- rience evacuation difficulties.(58, 61) Michot et al. (58) found a reduction of the explantation rate from 50% to 20% when com- paring their early and late experience. The authors related this improvement to better patient selection and liberal use of divert- ing colostomy. Parker et al. (63) found no difference in failure rates over time. A convened “best practice group” of colorectal surgeons, whose infection rate was 9% and long term functional device rate 82% have recently introduced a protocol to minimize infection.(64) ABS provides good continence in those patients who retain their device at the expense of significant surgical morbidity and possible chronic evacuation difficulties. Recent guidelines for intraoperative prevention of infection may help improve out- comes by decreasing morbidity. Dynamic graciloplasty The concept behind dynamic graciloplasty (DGP) is to create a sphincter with an autologous striated muscle wrap. The muscle is then stimulated with a constant low-frequency electric current by an implantable pulse generator with the goal of inducing the fast-twitch, readily fatigued (Type II) muscle fibers to change to slow-twitch, fatigue resistant (Type I) muscle fibers, similar to the normal external sphincter. A pedicled gracilis flap is harvested on one side, transposed, wrapped around the anus and anchored with its distal tendon to the contralateral ischial tuberosity. The electrode is implanted in the muscle or close to the obturator nerve and the stimulator is implanted in the lower abdomen, subcutaneously or beneath the rectus sheath. Increasing levels of neurostimulation are used to condition the muscle during the first 2 months. Thereafter, the patient can regulate defecation with the aid of an external magnet by turning the stimulator off to relax the muscle allowing emptying of the rectum and turning the stimulator back on to maintain continence. Similar to ABS, DGP is reserved as an alternative to colostomy for patients suffering severe FI unresponsive to simpler treat- ment. As opposed to the ABS, DPG involves transposition of healthy tissue and can be applied even to patients with severe loss of perineal tissue.  improved outcomes in colon and rectal surgery A systematic review of the literature through 1999 on DGP by the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical found that DGP was effective at restoring continence in 42 to 85% of patients but was associated with an average risk of complications of 1.12 per patient and reopera- tion of 0.14 to 1.07 per patient (65); none of the included studies provided a high level of evidence. Overall DGP related mortal- ity was 1% and the most common complications were infection (28%), hardware dysfunction, or displacement (15%) and leg pain (13%). The Dynamic Graciloplasty Therapy Study Group undertook a large international multicenter prospective trial including 115 eligible patients, 27 of whom had a preexisting functioning stoma.(66–68) The success rate, defined as 50% or more reduction in incontinent episodes, was 62% at 12 months and 56% at 24 months for nonstoma patients and 37.5% and 43% in patients with preexisting stoma at 12 and 24 months respec- tively. Significant improvement in quality of life subscales was noted. One patient died postoperatively and major complications requiring hospitalization or surgical intervention occurred 89 times in 61 (50%) patients; 90% resolved completely. Rongen et al. (69) from the Maastricht group reported the largest single center experience with DGP on 200 consecutive patients with a median follow-up of 5 years. The success rate (continent to solid and liq- uid stool) was 72%, ranging from 52% in patients with congenital FI to 82% in patients with traumatic FI. The success seemed to persist over time as complications decreased and technical suc- cess improved. Chronic evacuation problems persisted in 16% of the patients. The indications for sphincter replacement surgery either with ABS or DGP are decreasing in favor of SNS (70) given the significant difference in morbidity. DGP is not available in the USA as the producer of the stimulator (Medtronic Corporation, Minneapolis, MN) decided not to pursue FDA approval. Sacral Nerve Stimulation Sacral Nerve Stimulation (SNS) is an innovative and rapidly expanding treatment modality. It has been used for urinary incontinence since 1981 and was approved by the FDA for that indication in 1997. The observation that bowel symptoms simul- taneously improved in many patients led to the first implantation of a sacral nerve stimulator to treat FI in 1994.(71) In the USA, a multicenter study completed enrollment of 120 patients in 2006 and the manufacturer (Medtronic Corporation, Minneapolis, MN) is expected to pursue FDA approval in 2008. The goal of placing a stimulating electrode into the sacral foramina was to recruit residual function of the striated pelvic floor and exter- nal sphincter muscles. Initial selection criteria for SNS stipulated reduced or absent voluntary sphincter function, intact nerve-muscle connection and an intact sphincter muscle.(72) It became apparent that the effect of SNS was not limited to an increase of voluntary squeeze pressure. Somewhat inconclusive and often contradictory, studies suggest that SNS may decrease urge thresholds, reduce spon- taneous rectal motility, reduce spontaneous sphincter relaxation, and improve anal and perianal skin sensitivity.(72) Sheldon et al. (73) showed in a crossover study in 10 women with FI that SNS also affects the central nervous system; they documented a decrease in corticoanal excitability. More recently, in a cohort of patients with FI successfully treated with SNS, Gooneratne et al. (74) demonstrated a normalization of elevated levels of rectal mucosal substance P, a substance known to play a role in contractility and afferent signaling in visceral sensation. While the understanding of the physiology of SNS still remains unclear, patient selection has become more pragmatic. The efficacy of SNS can be tested on an individual patient temporarily with minimal consequences and a high predictive value of permanent therapeutic effect. The screening procedure consists of a percutane- ous stimulation of the S2–S4 roots on both sides. The testing is done under local or general anesthesia by insertion of a needle electrode into the dorsal sacral foramina. The site providing the most effective bellows-like motion of the pelvic floor along with plantar flexion of the first and second toes (typically S3 root) is selected for tempo- rary stimulation. Continuous stimulation is applied for a minimum of 1 week. If the stimulation is well tolerated and successful (50% or greater reduction in incontinent episodes per week or days with incontinence per week), a permanent pulse generator is connected to the electrode and implanted. Surgical replacement of the battery is necessary after 7–10 years for Interstim I and 5–7 years for the newer and smaller model Interstim II. More than 75% of patients tested with temporary stimulation will have a 50% or more improvement in symptoms, which is required to justify permanent implantation (Table 22.3). The therapeutic benefit seems to persist in studies with follow-up over 2 years.(75–77) SNS has been shown not only to decrease the frequency of FI but also to improve the ability to postpone defecation (76), improve sexual activity (78) and quality of life. (72, 79) A Swiss group performed a cost analysis on a cohort of 36 patients including expenses generated by failures and compli- cations and found that SNS is more cost efficient than colostomy or dynamic graciloplasty but obviously more expensive than conservative treatment alone.(80) The indications for SNS have progressively expanded. Accepted contraindications include conditions where implantation is impos- sible or too risky (e.g., spina bifida, pilonidal sinus, pyoderma gangrenosum), chronic diarrhea, irritable bowel syndrome, rec- tal prolapse, mental or physical inability to adhere to treatment, severe bleeding diathesis, pregnancy, and the presence of cardiac pacemaker or implantable defibrillator.(81) Earlier contraindica- tions such as previous rectal surgery, multiple sclerosis, Parkinson’s disease, and spinal cord injury have been recently challenged. (82) The most interesting controversial issue is the use of SNS in patients with FI and sphincter defects as these patients are tra- ditionally treated with sphincteroplasty. Initial studies did not include patients with sphincter defects except very minor ones. Dudding et al. (83) analyzed the 10 year experience with SNS at St. Mark’s hospital in the UK in an effort to identify predictive factors of success. Patients with evidence of sphincter trauma had a greater risk of failure compared to patients with intact sphincters (7/29 vs. 0/16, p=0.04). Conversely, in a retrospective study, Melenhorst et al. (84) compared a group of women with a functionally failed but anatomically intact previous sphincter repair to a group of women with an external sphincter defect of 17–30%. They found no significant difference in baseline characteristics and a similar outcome after a 2-year follow-up. In a controlled randomized study Tjandra et al. compared SNS to optimal medical treatment. Close to half of patients in the SNS arm had evidence of external  surgical treatment of fecal incontinence sphincter defect (120° or less) and more than half had a previous sphincter repair. Despite that, excellent results were achieved in the SNS arm as 66% of patients had a 75–100% reduction of inconti- nent episodes per week. On the contrary, patients in the medical treatment arm experienced no change in FI severity or FI-related quality of life scores. In absence of a randomized study that spe- cifically addresses the question, there is currently no evidence to support the idea that SNS should replace sphincteroplasty as avail- able studies are subject to important patient selection bias. Complications with SNS are rare and include wound problems (dehiscence, seroma, infection, bleeding), electrode dislodgment or fracture, pain at the site of the electrode or pulse generator, excessive tingling in the vaginal region, loss of effect, or deteriora- tion of bowel symptoms. Complications leading to explantation of the stimulator occur in approximately 5%.(72, 85) The role of SNS in the treatment of FI is expected to grow. Further understanding of the physiology involved may improve patient selection and stimulation modes. Peripheral nerve stimu- lation may render the technique simpler and applicable to patients with sacral abnormalities. Transcutaneous intermittent stimula- tion of the posterior tibial nerve has been reported to improve urinary continence and has been tried more recently in FI with encouraging preliminary results.(86, 87) Direct stimulation of the pudendal nerve is another field of investigation. Injectable bulking agents The goal of injectable bulking agents (IBA) is to restore a normal contour of the anal canal and add bulk to provide a better seal. IBA are usually injected under local anesthesia as an office or outpa- tient procedure; the injections may be into the submucosa or in the intersphincteric space and in all quadrants of the anal canal or at the site of a sphincter defect. Injection under ultrasound guidance in the intersphincteric space yielded better results than digitally guided injections in a randomized study.(88) Small studies have reported the use of Polytetrafluoroethylene (Teflon®), autologous fat, glutaraldehyde cross-linked collagen (Contigen®), textured silicon particles (Bioplastique®, renamed PTQ implants TM ), and pyrolytic carbon coated zirconium oxide beads (Durasphere®), but their true efficacy remains to be determined. The autologous materials are short lived and adipose tissue injections carry the risk of fat embolism. Cost as well as migration, ulceration, leak- age, infection, pain and local, or distal inflammatory reactions are concerns with the synthetic materials. The two most popular agents are PTQ implants TM and Durasphere®; both were shown to be safe and to attenuate severity of FI in a majority of patients. (88, 89) Quality of life improvements are less pronounced. Results after long-term follow-up are mixed and reinjection is necessary in some patients.(90, 91) An ongoing multicenter randomized placebo controlled study on Durasphere ® injection will hopefully help determine the place of IBA in the treatment of FI.(92, 93) The FDA has not yet approved any IBA for the use in FI. Antegrade colonic enema In 1990, Malone described the creation of a continent stoma using the appendix; this stoma was catheterized to perform ante grade colonic enemas (ACE) in five patients with intractable FI.(94) Modifications of the technique for patients in whom the appendix cannot be used due to previous appendectomy or fibrosis include construction of the stoma with a cecal flap or an “ileal neo-appen- dix”. ACE is used frequently in pediatric surgery for children with severe defecation disorders following anorectal malformations, spina bifida, sacrococcygeal teratomas and other abnormalities. Several small studies report its use in adults and even in patients undergoing abdomino-perineal resection in combination with a perineal colostomy.(95) Lefevre et al. (96) recently reported 25 adult patients with intractable FI treated with an ACE procedure. After a median follow-up of 21 months, 22 patients were avail- able: 4 had stopped performing enemas but 17 reported perfect cleanliness. They performed enemas once every 2–3 days spend- ing an average of 40 minutes. Stenosis of the mucocutaneous junction occurred in 20%; the majority responded to dilatation. It occurred more often in patients with native appendicostomy Table 22.3 Functional results of SNS in large studies. Author Year Study Design Temporary Stimulation (n) Permanent Stimulation (n %) f-up time months Baseline FI Episodes (n) Final FI Episodes (n) Fully Continent (n %) Matzel (76) 2004 prosp MC 37 34 (92) 24 8.3 b 0.75 12 (37) Jarrett (119) 2004 prosp MC 59 46 (78) 12 7.5 b 1 19 (41) Leroi (120) 2005 RCT MC DB cross 34 27 (79) 6–8 a 7 b 1 5 (26) Melenhorst (77) 2006 observ SC 134 100 (75) 26 31.3 c 4.4 nr Holzer (121) 2007 observ SC 36 29 (81) 35 7 c 2 nr Hetzer (79) 2007 observ SC 44 37 (84) 13 14 b 5 nr Tjandra (85) 2008 RCT MC 60 54 (90) 12° 9.5 b 3.1 25 (47) a. timepoint of evaluation. b. median number of FI episodes per week. c. median or mean number of FI episodes per 3 weeks; all differences statistically significant. prosp MC: prospective multicenter. observ SC: observational single center. RCT: randomized controlled trial. DB cross: double blind cross over.  improved outcomes in colon and rectal surgery than in those with an ileal neo-appendicostomy. Quality of life measures showed significant improvement for physical health but persistent low scores in psychological distress (96).(96) Others have reported similar success and complication rates.(97–99) As an option before an end colostomy, ACE may be appropriate in some patients with intractable FI, particularly those in whom incontinence is combined with constipation and who have failed other therapies. Postanal repair Sir Allan Parks developed the postanal repair in the 1970s relying on the theory that restoration of an obtuse anorectal angle would improve continence by recreating a flap valve mechanism. The pro- cedure was designed to treat neurogenic FI in patients with intact sphincters. Through a V-shaped incision posterior to the anus, the intersphincteric space is dissected proximal to the puborectalis; each muscle layer is plicated in the midline. If an anterior levatorplasty is added, the procedure is called total pelvic floor repair. Browning and Parks (100) reported good to excellent results in over 80% but others have failed to reproduce those findings.(101) Orrom et al. (102) demonstrated that there were no significant changes in the anorectal angle in patients after postanal repair questioning the concept of the operation. Results tend to deteriorate over time (103) which is an additional reason this treatment has fallen out of favor. Colostomy The colostomy is traditionally the end-stage treatment of intrac- table FI. When it becomes an option, the patient has usually failed several medical and surgical treatments and experienced years of misery and socially debilitating symptoms. The patient must accept a body image change and a whole new type of personal care. Having said that, a colostomy offers undeniable advantages. The patient can remain clean and be socially active. Perineal skin irritation is cured. Special diets or transit regulatory medicine can be stopped. On the other hand, there is a well-known morbidity related to colostomy including immediate postoperative but also longer term complications such as peristomal hernia, skin irrita- tion, and appliance problems. A systematic review compared DGP to colostomy in terms of mortality, morbidity, efficacy, and cost-effectiveness.(65) While it is intuitive that DGP resulted in better continence, mortality was similar and morbidity favored colostomy. Colostomy was more expensive than DGP in the long run provided that DGP does not fail resulting in a late colostomy. There are no good quality stud- ies comparing the quality of life of a patient with severe FI prior and after colostomy. A cross-sectional study comparing patients with rather moderate FI to patients with a well functioning colos- tomy (the majority secondary to rectal cancer) found no signifi- cant difference other than better average adjusted social function scores for ostomates.(104) The two groups however were differ- ent; patients with FI were younger and more often female, adding further bias to this study. Data from rectal cancer surgery indi- cate that an end colostomy after abdominoperineal resection does not always equate to a lower quality of life than sphincter sparing surgery.(105) The option of colostomy should be discussed early enough and adequate counseling should be offered to the patient to allow a mature decision to be taken. CONCLUSION Fecal incontinence is a common, underreported, devastating condition. The pathophysiology is complex and variable; the currently available instruments to measure the degree of dys- function of the different components are often imprecise and not standardized. The integration of quality of life scores and diary- based results has substantially improved the reporting of severity of FI in the literature. The initial step in management of patients with FI is to diagnose and treat appropriately underlying condi- tions of “pseudoincontinence” such as hemorrhoids, anal fistula, mucosal prolapse, rectal prolapse and diarrheal conditions. The first line treatment for true FI is medical and aims to regulate bowel frequency and consistency. Biofeedback may provide some relief to motivated patients. Those patients who fail medical treat- ment and are physically fit enough for surgery should undergo pelvic floor testing with sphincter imaging. Sphincteroplasty is appropriate for patients with significant sphincter defects and low anal canal pressures. 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