No systematic review has examined the collective randomized and nonrandomized evidence for fecal incontinence treatment effectiveness across the range of surgical treatments.
The purpose of this study was to assess the efficacy, comparative effectiveness, and harms of surgical treatments for fecal incontinence in adults.
Ovid MEDLINE, EMBASE, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine, and the Cochrane Central Register of Controlled Trials, as well as hand searches of systematic reviews, were used as data sources.
Two investigators screened abstracts for eligibility (surgical treatment of fecal incontinence in adults, published 1980–2015, randomized controlled trial or observational study with comparator; case series were included for adverse effects). Full-text articles were reviewed for patient-reported outcomes. We extracted data, assessed study risk of bias, and evaluated strength of evidence for each treatment–outcome combination.
Surgical treatments for fecal incontinence were included interventions.
Fecal incontinence episodes/severity, quality of life, urgency, and pain were measured.
Twenty-two studies met inclusion criteria (13 randomized trials and 9 observational trials); 53 case series were included for harms. Most patients were middle-aged women with mixed FI etiologies. Intervention and outcome heterogeneity precluded meta-analysis. Evidence was insufficient for all of the surgical comparisons. Few studies examined the same comparisons; no studies were high quality. Functional improvements varied; some authors excluded those patients with complications or lost to follow-up from analyses. Complications ranged from minor to major (infection, bowel obstruction, perforation, and fistula) and were most frequent after the artificial bowel sphincter (22%–100%). Major surgical complications often required reoperation; few required permanent colostomy.
Most evidence is intermediate term, with small patient samples and substantial methodologic limitations.
Evidence was insufficient to support clinical or policy decisions for any surgical treatments for fecal incontinence in adults. More invasive surgical procedures had substantial complications. The lack of compliance with study reporting standards is a modifiable impediment in the field. Future studies should focus on longer-term outcomes and attempt to identify subgroups of adults who might benefit from specific procedures.
1 Minnesota Evidence-based Practice Center, Division of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis, Minnesota
2 Department of Epidemiology, School of Public Health, University of Minnesota, Minneapolis, Minnesota
3 Colon and Rectal Surgery, University of Minnesota, Minneapolis, Minnesota
4 School of Nursing, University of Minnesota, Minneapolis, Minnesota
Funding/Support: This project was funded under contract No. 290-2012-00016-I from the Agency for Healthcare Research and Quality, US Department of Health and Human Services.
Financial Disclosure: Dr Bliss was subcontracted from Vital Sims, Inc, for development of an educational simulation computer game about incontinence-associated skin damage; received a research grant from Hartmann USA for measuring the pH of skin of nursing home residents with incontinence; and has a consulting agreement with 3M (less than $3000/year).
Correspondence: Mary L. Forte, Ph.D., D.C., Minnesota Evidence-based Practice Center, School of Public Health, University of Minnesota, D330-5 Mayo (MMC 729), 420 Delaware St SE, Minneapolis, MN 55455. E-mail: email@example.com