Fistulectomy with primary sphincter reconstruction in the treatment of high transsphincteric anal fistulas.

PURPOSE: The treatment of transsphincteric anal fistulas is a challenge between recurrence rate and incontinence. Many surgical and conservative procedures have been described in the treatment of anal fistulas. Fistulectomy and primary sphincter reconstruction (FPSR) has not gained great popularity in this field due to the risk of sphincter damage. The aim of this study is to evaluate FPSR in the treatment of transsphincteric fistulas. METHODS: We retrospectively analyzed 50 patients with high transsphincteric fistulas of cryptoglandular origin that were treated with FPSR between 2005 and 2008. Preoperative assessment included physical and proctologic examination. Continence and pain scores were evaluated preoperatively and postoperatively. RESULTS: In our 50 patients, 22 patients (44 %) had a previous proctologic operation and 11 patients (22 %) presented with recurrent fistulas. The fistulas existed for an average of 8 months. The operation time was 28 ± 16 min. Mean follow-up was 22± months. The fistula healed in 44 patients (88 %) who developed no recurrence. In five patients (10 %), the fistula healed, but they developed a recurrence in the observation period. In one patient (2 %), the fistula did not heal. Three patients developed low-grade incontinence for flatus, and one patient with 2° incontinence improved. Preoperatively and postoperatively calculated continence and pain scores showed a slight but significant elevation in the Clinical Continence Score, the German Society of Coloproctology Score showed no significant difference, and preexisting pain was reduced significantly by surgery. CONCLUSIONS: FPSR is a safe surgical procedure for the treatment of high transsphincteric anal fistula. The primary healing rate is high with a low risk of recurrence or incontinence.

Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial.

BACKGROUND: In the nonsurgical treatment of anal incontinence, the combination of amplitude-modulated medium-frequency stimulation and electromyographic biofeedback (EMG-BF), known as triple-target treatment (3T), is superior to EMG-BF alone. The aim of this trial is to compare 3T with the standard treatment, low-frequency stimulation (LFS). METHODS: 80 patients with anal incontinence of Grade I or higher who presented to physicians or centers specialized in coloproctology were enrolled in this multicenter randomized trial with blinded observer. The trial had an open parallel-group design. Randomization was performed centrally by telephone. The primary endpoint was the Cleveland Clinic Score (CCS) after self-training at home with either 3T or LFS in two 20-minute sessions per day for 6 months. The secondary endpoints included the proportion of patients regaining continence, and the patients' quality of life (QoL). On completion of the trial as planned, the results were evaluated with an intention-to-treat analysis. STUDY REGISTRATION: DRKS00000138 (http://register.germanctr.de). RESULTS: 39 patients were randomized to 3T, and 41 to LFS. After 6 months of treatment, the CCS (mean ± standard deviation) was 3.1 ± 4.2 in the 3T group and 9.6 ± 3.9 in the LFS group. The median improvement in the CCS at 6 months compared to baseline was 7 points greater in the 3T group than in the LFS group (95% CI: 5-9, p<0.001). Anal continence was regained by 54% of the 3T patients, but none of the LFS patients (95% CI for the difference: 37.18% - 69.91%, p<0.001). QoL scores were higher in all dimensions in the 3T group than in the LFS group. No major adverse effects occurred in either group. CONCLUSION: 3T is superior to LFS in the treatment of anal incontinence. The available evidence suggests that the success of 3T is based on the combined effect of biofeedback and medium-frequency stimulation. LFS of the type applied in this trial has no effect. 3T should be used in routine clinical practice instead of LFS.

Does the STARR procedure change the pelvic floor: a preoperative and postoperative study with dynamic pelvic floor MRI.

BACKGROUND: Obstructed defecation syndrome is a multifactorial disorder of the defecation process. Stapled transanal rectal resection has been used to restore function in patients suffering from obstructed defecation syndrome. OBJECTIVE: The aim of this study was to use preoperative and postoperative dynamic pelvic floor MRI combined with clinical parameters to evaluate the outcome of stapled transanal rectal resection. DESIGN AND SETTING: A prospective cohort study was conducted in a tertiary care center. PATIENTS: A group of 140 women with obstructed defecation syndrome were evaluated. INTERVENTION: All 140 patients were initially treated conservatively with laxatives, increased fluid intake, pelvic floor exercises, and biofeedback. Stapled transanal rectal resection was performed in 30 patients with rectocele who did not show improvement in symptoms after at least 6 months of conservative treatment. MAIN OUTCOME MEASURES: Preoperative diagnostic workup consisted of dynamic pelvic floor MRI, clinical examination, coloscopy, and clinical scores (Cleveland Clinic constipation score, German Working group on Coloproctology continence score, and SF-36 quality-of-life questionnaire). Postoperatively, patients were reevaluated at 3 months by means of dynamic pelvic floor MRI, clinical examination, and clinical scores; clinical scores were repeated at 6 months after the operation. RESULTS: Postoperative dynamic pelvic floor MRI performed after a median of 3.4 months showed a decrease in rectocele size from 3.3 (interquartile range, 2.8-3.8) cm to 1.5 (1.2-2) cm (P < .001). The number of patients with intussusception decreased from 21 (70%) before the operation to none after the operation (P < .001). The size of cystoceles did not change. The number of patients with incomplete evacuation was significantly reduced (P < .001). With a mean follow-up of 18 ± 4 months, patients showed a significant improvement in the quality-of-life score (P < .001) but not in the continence scores. CONCLUSIONS: Stapled transanal rectal resection is an effective treatment option for patients with obstructed defecation syndrome associated with rectocele and intussusception.

Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: the 3T-AI study.

PURPOSE: The efficacy of EMG-biofeedback and low-frequency electrical stimulation for the treatment of anal incontinence has not been proven. Our purpose was to evaluate a novel therapeutic concept, termed triple target treatment, which combines amplitude-modulated medium-frequency stimulation and EMG-biofeedback. METHODS: Patients with anal incontinence were randomly assigned to the triple target regimen or EMG-biofeedback alone for a 9-month treatment period in a multicenter randomized clinical trial with blinded observers (ClincialTrials.gov registration number NCT00525291). Primary end points were changes in the Cleveland Clinic score and the adapted St. Mark's (Vaizey) score at 9 months compared with baseline. Secondary end points included therapy acceptance and proportion of patients achieving continence or improvement in grade or frequency of incontinence. RESULTS: We enrolled 158 patients with anal incontinence. The median decrease in the Cleveland Clinic score from baseline to 9 months was 3 points greater for the triple target regimen than for EMG-biofeedback (95% CI, 1-4; P = .0024). The improvement was 8 points for the triple target regimen (95% CI, 7-9) and 5 points for EMG-biofeedback (95% CI, 4-7). Results were similar for the Vaizey score. Of patients treated for at least 3 months, continence was achieved by 50% of patients with the triple target regimen and 25.8% of those with EMG-biofeedback. CONCLUSIONS: The combination of amplitude-modulated medium-frequency electrostimulation with EMG-biofeedback in the triple target regimen is superior to EMG-biofeedback alone in the treatment of anal incontinence. Therapy programs for fecal incontinence are most effective if patients participate for longer than 2 to 3 months.

Transvaginal rectal repair: a new treatment option for symptomatic rectocele?

PURPOSE: Widely differing surgical methods have been propagated to correct symptomatic rectocele. With transvaginal rectal repair (TVRR), we evaluate a method to reestablish the continuity of the rectal muscle wall, strengthen the weakened tunica muscularis, and restore normal rectal capacity and function. METHODS: Between 1997 and 2003, 102 female patients were treated by TVRR in cases of symptomatic rectocele. Patients without improvement following a stringent conservative treatment for a minimum of 3-6 months were selected for TVRR procedure. Patients with intussusception and slow-transit constipation were excluded from the study. To achieve optimal stabilization of the rectal wall, a transverse gathering of the rectocele was performed by a transvaginal access. RESULTS: Average patient age was 60.9 years (47-76 years), operation time was 36.5 minutes (29-67 min.), in-hospital treatment lasted 4.1 days (2-7 days), and follow-up was 18.1 months (3-48 months). We observed complications in 11% of cases. Three months after the operation, 81% of the patients were symptom-free or improved. Following an average observation time of 18.1 months (3-48 months), 70% were still symptom-free or improved. CONCLUSIONS: TVRR allows easy access for rectocele repair with a low rate of complications.

Surgical treatment of complex anal fistulas with the anal fistula plug: a prospective, multicenter study.

PURPOSE: This study was designed to analyze the efficacy of the Surgisis Anal Fistula Plug for the closure of transsphincteric anorectal fistulas. METHODS: Patients with single transsphincteric anorectal fistulas were prospectively enrolled. Setons were used in all tracts for at least eight weeks before surgery. Continence, surgical variables, complications, and healing rates were recorded. Surgery was performed in a standardized manner. The fistula tract and external opening were debrided, the tract was irrigated, and the plug was placed. The external opening was left open. Success was defined as the absence of drainage and closure of the external opening. Follow-up examinations were performed at 2 days, 2, 4, 6, and 12 weeks, and 6 and 12 months after surgery. RESULTS: Sixty patients were enrolled. Seventeen patients were smokers, and ten had diabetes mellitus. The mean surgical time was 23 (range, 13-50) minutes; no morbidity occurred. The overall success rate after 12 months was 62%. Nineteen fistulas recurred, and four fistulas never completely healed. The success rate was significantly lower in smokers and diabetics. Two patients had a plug dislodgement, and plugs were successfully replaced. No change in continence was observed. CONCLUSION: Because there is still no standard for the treatment of high transsphincteric fistulas and because recurrence rates are high for all procedures performed, new techniques are needed for this complex disease. Our success rate of 62% is promising because this technique can be used as a first approach to close the fistula tract without destruction of the sphincter muscle.