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.

Fecal incontinence: part 4 of a series of articles on incontinence.

BACKGROUND: The aging of the population will make fecal incontinence an increasingly important socioeconomic problem in the coming decades. Already today, the cost to society of treating incontinence with inserts, diapers, and closed systems exceeds the total cost of all cardiac and anti-inflammatory medications. METHODS: This article is based on a selective review of the literature and on clinical experience. No meta-analyses on this topic have yet been published. RESULTS: Surveys in highly industrialized countries in the Western Hemisphere have shown that about 5% of the population suffers from fecal incontinence of varying degrees of severity. This condition will become more common, in both relative and absolute terms, in the coming decades. Various methods of care and therapy are currently available for fecal incontinence, yet many patients do not seek medical help for it because of embarrassment. Thus, its true prevalence is certainly higher than the surveys imply. CONCLUSION: The challenge today, therefore, is not just to encourage patients to seek medical help early, but also to raise physicians' awareness of fecal incontinence and their readiness to treat it, so that they can provide competent individual counseling and treatment to all patients who suffer from it.

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.

Anal cancer treated with radio-chemotherapy: correlation between length of treatment interruption and outcome.

AIM: The purpose of this study was the evaluation of the feasibility and outcome of definitive radio-chemotherapy without split-course technique but with individualised short treatment interruption in anal cancer patients. METHOD: Between 1993 and 2008, 101 patients with anal cancer were treated in our institution with definitive radio-chemotherapy with individualised short treatment interruptions. Treatment was halted independent of dose in case of acute grade 3 toxicities and started again until improvement. Short interruption was defined as completing treatment without exceeding six cumulative treatment days beyond a scheduled plan; otherwise, it was defined as prolonged interruption. RESULTS: Median overall treatment time was 47 days corresponding to an interruption of six cumulative treatment days. Fifty-one patients (50%) had treatment interruption of

[Outpatient surgery in proctology]. / Ambulante Operationen in der Proktologie.

Proctological surgery can be carried out increasingly on an outpatient basis and thus more cost-effectively. The reasons for this are, in addition to modern anaesthetic procedures, short operation times and low complication rates in numerous proctological operations. Fissurectomies, individual haemorrhoidectomies, operations on uncomplicated fistulae and benign anal tumours only rarely need to be carried out nowadays under inpatient conditions. The conditions for successful outpatient surgery are: appropriate diagnosis of the indication, selection of the patients with respect to their suitability for surgery and standardised follow-up care.