The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial.

BACKGROUND: The anal fistula plug was developed as an alternative treatment for perianal fistulas. OBJECTIVE: This study aimed to compare the anal fistula plug with the mucosal advancement flap for the treatment of high transsphincteric fistulas. DESIGN: This study was a double-blinded, multicenter, randomized trial. PATIENTS: Sixty patients with perianal fistulas were randomly assigned to receive an anal fistula plug or a mucosal advancement flap and were blinded for the type of treatment. MAIN OUTCOME MEASURES: The outcome measures comprised the closure rate, postoperative pain, continence (colorectal functional outcome, Vaizey, and Wexner scores), and quality of life. Closure was determined by clinical examination by a surgeon blinded for the intervention. RESULTS: At a follow-up of 11 months the recurrence rates were 71% (n = 22) in the anal fistula plug group and 52% (n = 15) in the mucosal advancement flap group, which was not significantly different. There were no significant differences in postoperative pain, in pre- and postoperative incontinence scores, soiling, and quality of life. CONCLUSIONS: The results of the anal fistula plug and advancement flap procedures are disappointing in the multicenter setting. There were no significant differences in recurrence, functional outcome, and quality of life between the plug and the advancement flap. Because the plug is simple to apply and minimally invasive, it can be considered as an initial treatment option for high transsphincteric fistulas.

The anal fistula plug versus the mucosal advancement flap for the treatment of anorectal fistula (PLUG trial).

BACKGROUND: Low transsphincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the anal fistula plug showed promising results. The anal fistula plug trial is designed to compare the anal fistula plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain, and quality of life. METHODS/DESIGN: The PLUG trial is a randomized controlled multicenter trial. Sixty patients with high perianal fistulas of cryptoglandular origin will be randomized to either the fistula plug or the mucosal advancement flap. Study parameters will be anorectal fistula closure-rate, continence, post-operative pain, and quality of life. Patients will be followed-up at two weeks, four weeks, and 16 weeks. At the final follow-up closure rate is determined by clinical examination by a surgeon blinded for the intervention. DISCUSSION: Before broadly implementing the anal fistula plug results of randomized trials using the plug should be awaited. This randomized controlled trial comparing the anal fistula plug and the mucosal advancement flap should provide evidence regarding the effectiveness of the anal fistula plug in the treatment of high perianal fistulas. TRIAL REGISTRATION: ISRCTN: 97376902.

The role of endoluminal imaging in clinical outcome of overlapping anterior anal sphincter repair in patients with fecal incontinence.

OBJECTIVE: Anterior sphincter repair has become the operation of choice in patients with fecal incontinence who have defects of the external anal sphincter (EAS), but not all patients benefit from surgery. The aim of this study was to investigate whether endoluminal imaging can identify determinants that play a role in the outcome of sphincter repair. SUBJECTS AND METHODS: Thirty fecal incontinent patients with an EAS defect were included. The severity of incontinence was evaluated pre- and postoperatively using the Vaizey incontinence score. Patients underwent endoanal MRI and endoanal sonography before and after sphincter repair. We evaluated the association between preoperatively assessed EAS measurements with outcome and postoperatively depicted residual defects, atrophy, tissue at overlap, and sphincter overlap with clinical outcome. RESULTS: After surgery, the mean Vaizey score in 30 patients (97% females; mean age, 50 years) had improved from 18 to 13 (p < 0.001). MRI showed that baseline measurement of preserved EAS thickness correlated with a better outcome (r = 0.42; p = 0.03). Clinical outcome did not differ between patients with and those without a persistent EAS defect (p = 0.54) or EAS atrophy (p = 0.26) depicted on MRI. Patients with a visible overlap and less than 20% fat tissue had a better outcome than patients with nonvisible, fatty overlap (decrease in Vaizey score, 7 vs 2 points, respectively; p = 0.04). Sonography showed that patients with a persistent EAS defect had a worse outcome than those without an EAS defect (17 vs 10 points, respectively; p = 0.003). CONCLUSION: Endoanal MRI was useful in determining EAS thickness and structure, and endoanal sonography was effective in depicting residual EAS defects.

Robot-assisted laparoscopic rectovaginopexy for rectal prolapse: a prospective cohort study on feasibility and safety.

Robotic systems may be particularly supportive for procedures requiring careful pelvic dissection and suturing in the Douglas pouch, as in surgery for rectal prolapse. Studies reporting robot-assisted laparoscopic rectovaginopexy for rectal prolapse, however, are scarce. This prospective cohort study evaluated the outcome of this technique up to one year after surgery. From January 2005 to June 2006, 15 consecutive patients with a rectal prolapse, either with or without a concomitant rectocele or enterocele, underwent robot-assisted laparoscopic rectovaginopexy with support of the da Vinci robotic system. A prospective cohort study was performed on operating times, blood loss, intra-operative and post-operative complications, and outcome at a minimum of one year after surgery. Median age at time of operation was 62 years (33-72) and median body mass index 24.9 (20.9-33.9). Median robot set-up time was 10 min (3-15) and median skin-to-skin operating time was 160 min (120-180). No conversions to open surgery were necessary. No in-hospital complications occurred and there was no mortality. Median hospital stay was four days (2-9). During one year follow-up, two patients needed surgical reintervention. One patient was operated for recurrent enterocele and rectocele one week after surgery. In another patient an incisional hernia at the camera port occurred three months after surgery. At one year after surgery, 87% of patients claimed to be satisfied with their postoperative result. Robot-assisted laparoscopic rectovaginopexy proved to be an effective technique with favourable outcomes in most patients in this prospective series. The operating team experienced the support of the robotic system as beneficial, especially during the dissection of the rectovaginal plane and suturing in the Douglas pouch.

Anal inspection and digital rectal examination compared to anorectal physiology tests and endoanal ultrasonography in evaluating fecal incontinence.

BACKGROUND: Anal inspection and digital rectal examination are routinely performed in fecal incontinent patients but it is not clear to what extent they contribute to the diagnostic work-up. We examined if and how findings of anal inspection and rectal examination are associated with anorectal function tests and endoanal ultrasonography. METHODS: A cohort of fecal incontinent patients (n=312, 90% females; mean age 59) prospectively underwent anal inspection and rectal examination. Findings were compared with results of anorectal function tests and endoanal ultrasonography. RESULTS: Absent, decreased and normal resting and squeeze pressures at rectal examination correlated to some extent with mean (+/-SD) manometric findings: mean resting pressure 41.3 (+/-20), 43.8 (+/-20) and 61.6 (+/-23) Hg (p<0.001); incremental squeeze pressure 20.6 (+/-20), 38.4 (+/-31) and 62.4 (+/-34) Hg (p<0.001). External anal sphincter defects at rectal examination were confirmed with endoanal ultrasonography for defects <90 degrees in 36% (37/103); for defects between 90-150 degrees in 61% (20/33); for defects between 150-270 degrees in 100% (6/6). Patients with anal scar tissue at anal inspection had lower incremental squeeze pressures (p=0.04); patients with a gaping anus had lower resting pressures (p=0.013) at anorectal manometry. All other findings were not related to any anorectal function test or endoanal ultrasonography. CONCLUSIONS: Anal inspection and digital rectal examination can give accurate information about internal and external anal sphincter function but are inaccurate for determining external anal sphincter defects <90 degrees. Therefore, a sufficient diagnostic work-up should comprise at least rectal examination, anal inspection and endoanal ultrasonography.

Functional changes after physiotherapy in fecal incontinence.

BACKGROUND: Physiotherapy is a common treatment option in patients with fecal incontinence. Although physiotherapy may result in relief of symptoms, to what extent improvement is associated with changes in anorectal function is still unclear. AIM: The aim of the present study was to investigate prospectively how anorectal function changes with physiotherapy and whether these changes are related to changes in fecal incontinence score. METHODS: Consenting consecutive patients (n=266) with fecal incontinence (91% women; mean age, 59 years) underwent anorectal manometry, anal and rectal mucosal sensitivity measurements, and rectal capacity measurement at baseline and after nine sessions of standardized pelvic floor physiotherapy. These findings were compared with changes in Vaizey incontinence score. RESULTS: On follow-up 3 months after physiotherapy, squeeze pressure (p=0.028), as well as urge sensation threshold (p=0.046) and maximum tolerable volume (p=0.018), had increased significantly. The extent of improvement was not related to age, duration of fecal incontinence, menopause, and endosonography findings. All other anorectal functions did not change. An improvement in the Vaizey score was moderately correlated with an increase in incremental squeeze pressure (r=0.14, p=0.04) and a decrease in anal mucosal sensitivity threshold (r=0.20, p=0.01). CONCLUSIONS: Physiotherapy improves squeeze pressure, urge sensation, and maximum tolerable volume. However, improved anorectal function does not always result in a decrease in fecal incontinence complaints.

Relationship between external anal sphincter atrophy at endoanal magnetic resonance imaging and clinical, functional, and anatomic characteristics in patients with fecal incontinence.

PURPOSE: External anal sphincter atrophy at endoanal magnetic resonance imaging has been associated with poor outcome of anal sphincter repair. We studied the relationship between external anal sphincter atrophy on endoanal magnetic resonance imaging and clinical, functional, and anatomic characteristics in patients with fecal incontinence. METHODS: In 200 patients (mean Vaizey score, 18 (+/-2.9 standard deviation)) magnetic resonance images were evaluated for external anal sphincter atrophy (none, mild, or severe) by radiologists blinded to anorectal functional test results and details from medical history. Subgroups of patients with and without atrophy were compared for medical history, anal manometry, pudendal nerve latency testing, anal sensitivity testing, external anal sphincter thickness, and external anal sphincter defects. Whenever significant differences were detected, we tested for differences between patients with mild and severe atrophy. RESULTS: External anal sphincter atrophy was demonstrated in 123 patients (62 percent): graded as mild in 79 (40 percent), and severe in 44 patients (22 percent). Patients with atrophy were more often female (P < 0.001) and older (P = 0.003). They had a lower maximal squeeze (P = 0.01) and squeeze increment pressure (P < 0.001). Patients with severe atrophy had a lower maximal squeeze (P = 0.003) and squeeze increment pressure (P < 0.001) than patients with mild atrophy. These effects were not attenuated by potential confounding variables. Patients with atrophy could not be identified a priori by other characteristics. CONCLUSIONS: External anal sphincter atrophy at endoanal magnetic resonance imaging was depicted in 62 percent of patients, varying from mild to severe. Because increasing levels of atrophy were associated with impaired squeeze function, further studies are needed to evaluate whether grading atrophy is clinically valuable in selecting patients for anal sphincter repair.

Prospective assessment of interobserver agreement for defecography in fecal incontinence.

OBJECTIVE: The primary aim of our study was to determine the interobserver agreement of defecography in diagnosing enterocele, anterior rectocele, intussusception, and anismus in fecal-incontinent patients. The subsidiary aim was to evaluate the influence of level of experience on interpreting defecography. SUBJECTS AND METHODS: Defecography was performed in 105 consecutive fecal-incontinent patients. Observers were classified by level of experience and their findings were compared with the findings of an expert radiologist. The quality of the expert radiologist's findings was evaluated by an intraobserver agreement procedure. RESULTS: Intraobserver agreement was good to very good except for anismus: incomplete evacuation after 30 sec (kappa, 0.55) and puborectalis impression (kappa, 0.54). Interobserver agreement for enterocele and rectocele was good (kappa, 0.66 for both) and for intussusception, fair (kappa, 0.29). Interobserver agreement for anismus: incomplete evacuation after 30 sec was moderate (kappa, 0.47), and for anismus: puborectalis impression was fair (kappa, 0.24). Agreement in grading of enterocele and rectocele was good (kappa, 0.64 and 0.72, respectively) and for intussusception, fair (kappa, 0.39). Agreement separated by experience level was very good for rectocele (kappa, 0.83) and grading of rectoceles (kappa, 0.83) and moderate for intussusception (kappa, 0.44) at the most experienced level. For enterocele and grading, experience level did not influence the reproducibility. CONCLUSION: Reproducibility for enterocele, anterior rectocele, and severity grading is good, but for intussusception is fair to moderate. For anismus, the diagnosis of incomplete evacuation after 30 sec is more reproducible than puborectalis impression. The level of experience seems to play a role in diagnosing anterior rectocele and its grading and in diagnosing intussusception.

Robot-assisted endoscopic surgery: a four-year single-center experience.

BACKGROUND: Robotic systems were introduced in the late 1990s with the objective to overcome the technical limitations of endoscopic surgery. In this prospective cohort study the potential safety, feasibility, pitfalls and challenges of robotic systems in gastrointestinal endoscopic surgery are assessed and our vision on future perspectives is presented. METHODS: Between August 2000 and December 2004, 208 procedures were performed with support of the Intuitive Surgical da Vincitrade mark robotic system. We started with cholecystectomies (40) and Nissen fundoplications (41) to gain experience with robot-assisted surgery. In the following years more complex procedures were carried out, i.e. colorectal procedures (7), type III/IV paraesophageal hernia repair (32), redo Nissen fundoplications (9), Heller myotomies (24), esophageal resections (22), rectopexies (16) and aortobifemoral bypasses (3). RESULTS: The median robotic set-up time was 13 min, and 7 min in the last 50 procedures. The median operating time for the total of procedures was 120 min (45-420) and the median blood loss was 30 ml (0-800). Fourteen procedures were converted to open surgery (6.7%). Equipment-related problems, such as start-up failures and positioning difficulties of the robotic arms, were encountered in 11 cases (5.3%). Postoperative complications were seen in 11 patients (11/176, 6.3%) after robot-assisted laparoscopic procedures. Pulmonary complications occurred in 11 patients, cardiac in 3, anastomic leakage in 3, chylous leakage in 3 and vocal cord paralysis in 3 after thoracoscopic esophagolymphadenectomy for esophageal cancer. One patient died 12 days after esophageal resection (0.5%). CONCLUSION: During the implementation of this robotic system, we experienced an obvious learning curve, particularly with regard to the positioning of the robot cart and communication between the surgeon and operating team. After 4 years, we have experienced that the merits of the current generation of this technology probably is preserved to complex endoscopic procedures with delicate dissection and suturing. In the nearby future we will focus on the treatment of motility disorders and malignancies of the esophagus and stomach. The position of the robot in the endoscopic operating room will have to be clarified by the outcome of prospective research. Furthermore, priorities have to be acclaimed on technical sophistication and cost reduction of these systems.