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Systematic Review of Surgical Treatments for Fecal Incontinence

Forte, Mary L. Ph.D., D.C.1; Andrade, Kate E. M.P.H.2; Lowry, Ann C. M.D.3; Butler, Mary Ph.D., M.B.A.1; Bliss, Donna Z. Ph.D., R.N.4; Kane, Robert L. M.D.1

Author Information
Diseases of the Colon & Rectum: May 2016 - Volume 59 - Issue 5 - p 443-469
doi: 10.1097/DCR.0000000000000594
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Abstract

Fecal incontinence (FI) is characterized by the frequency of episodes and the consistency of the feces.1–3 FI severity varies widely. The negative psychological effects, social stigma, and reduced quality of life surrounding FI can be devastating for affected adults.3

In individual adults, multiple causes of FI are common, and a dominant etiology may not be determinable. Risk factors for FI include older age, female sex, anal sphincter injury, obstetrical trauma, chronic diarrhea, nerve damage, postsurgical or postradiation complications, cognitive impairment, and other factors, such as severe constipation.4,5

Treatment goals are to decrease the frequency and severity of FI episodes, and the multiple contributing factors of FIs often necessitate a combination of treatments. Most treatments are aimed at symptom reduction; few treatments, if any, afford long-term cures for FI. FI treatments typically progress from easy-to-implement nonsurgical treatments (dietary fiber or drugs) to more intensive (pelvic floor muscle training with biofeedback) or invasive nonsurgical (anal sphincter tissue bulking injections) to surgical treatments. Surgery is typically considered after other approaches have failed. Nonsurgical treatments may also be used to complement surgical treatment. Not all treatments are appropriate for all patients, because FI etiologies and other patient factors dictate feasible treatment options.1

Nonsurgical treatments include dietary fiber supplementation,5 stool-modifying drugs,6 pelvic floor muscle training with biofeedback,7,8 anal plugs,9,10 rectal irrigation,10,11 or combinations thereof.5,7 More invasive injections of biocompatible tissue-bulking agents into the anal canal walls may also be used,12 and other nonsurgical interventions are emerging.13,14 Surgical procedures used to treat FI in the United States include sacral nerve stimulation (SNS), radiofrequency anal sphincter remodeling, antegrade colonic enema (ACE), sphincteroplasty, sphincter replacement, surgical correction of conditions that can result in FI (rectal prolapse, hemorrhoids, or rectocele), or, when all other treatments fail, colostomy.1,5,15–17

This review seeks to increase the breadth and use of the review findings to better inform clinical decision making and research needs. Although many recent systematic reviews have assessed the effectiveness of surgery or SNS for FI using randomized clinical trials (RCTs),15–21 no systematic review has examined the collective randomized and nonrandomized evidence for FI treatment effectiveness across the range of surgical treatments. Given the heterogeneous population of adults afflicted with FI, this review included observational studies with control groups to encompass a broader range of patients and prognostic variables that are often unavailable from limited RCT samples. Case series were included for harms information that is typically limited in small surgical RCTs. Our review addressed the following 2 questions:

  • 1) What is the comparative effectiveness of surgical treatments to improve quality of life and continence and lessen the severity of FI in affected adults?
  • 2) What adverse effects are associated with specific surgical treatments for adults with FI?

PATIENTS AND METHODS

Our a priori review protocol is posted on the Effective Health Care Program Web site (http://www.effectivehealthcare.ahrq.gov/) of the Agency for Healthcare Research and Quality. Bibliographic database searches identified RCTs and observational studies published from 1980 to June 2015 on treatments for adults with FI from Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Central Register of Controlled Trials, Ovid Physiotherapy Evidence Database, and Allied and Complementary Medicine. Appendix Table 1 contains our Medline search strategy, which was modified for other databases. We also hand-searched reference lists of related systematic reviews published since 2007. Grey literature searches were also conducted.

Studies were selected based on the Population, Intervention, Comparator, Outcomes, Timing, and Setting framework and on the inclusion criteria in Appendix Table 2. Two investigators independently reviewed titles and abstracts for FI surgical treatment studies with at least 1 patient-centered outcome. Citations deemed potentially eligible by either investigator underwent full-text screening. Differences in screening decisions were resolved by consultation with a third investigator. We extracted data into evidence tables by the type of study design. Initial data abstraction was quality checked by a second investigator.

Individual study risk of bias (study quality) was assessed by 2 independent investigators using instruments specific to each study design; discrepancies were reconciled with a third investigator. We used a modified Cochrane risk-of-bias tool22 for RCTs and an instrument for observational studies based on the Observational Studies Risk of Bias and Precision Item Bank by Research Triangle Inc.23 Each study was assigned an overall summary risk-of-bias rating of low, moderate, or high based on the collective risk of bias inherent in each domain.24

Strength-of-evidence assessment was based on 5 domains:25 1) risk of bias/study limitations (internal validity), 2) directness (link between the intervention and outcome), 3) consistency (effect direction and magnitude), 4) precision (degree of certainty around an estimate), and 5) reporting bias. The possible strength-of-evidence grades25 ranged from high to insufficient (evidence is unavailable or does not permit a conclusion). To assign a grade of low strength of evidence rather than insufficient, we required at least 2 moderate risk of bias studies or 1 sufficiently powered, low risk-of-bias RCT for a specific treatment–outcome comparison. We graded strength of evidence for treatment–outcome combinations that assessed FI severity/impact or quality of life in studies with low or moderate risk of bias; literature comparisons that were unavailable or did not meet this evidence quality minimum were labeled as insufficient evidence on which to draw conclusions about treatment-versus-comparator effectiveness on a specific outcome.

Meta-analysis was not possible because of intervention and outcome heterogeneity. This review was funded by Agency for Healthcare Research and Quality under the US Department of Health and Human Services.26

RESULTS

We identified 2978 unique citations (Appendix Fig. 1) from all of the databases combined. Of those, 22 studies met inclusion criteria, 13 RCTs and 9 observational studies with comparators; 53 case series were also included for adverse effects. Because of variability in follow-up, we considered evidence as short term (if <3 months27–29), intermediate term (3–6 months30–36), or long term (>6 months31–33,36–39).

Comparative Effectiveness

We included 13 surgical RCTs (Table 1) and 9 observational studies with comparison groups (Table 2) that assessed the comparative effectiveness of surgical treatments to lessen the severity of FI or to improve quality of life. The average age of enrolled adults was 55 to 65 years in 75% of surgical RCTs. Of adults enrolled in the 12 surgical RCTs that reported patient sex (Table 1), 95% were women. Eleven RCTs (85%) and 4 observational studies with comparison groups (44%) enrolled 40 or fewer adults (Table 1). Nearly two thirds (62%) of RCTs and 56% of observational studies enrolled adults with mixed FI etiologies.

TABLE 1.
TABLE 1.:
Comparative effectiveness of surgical treatments for fecal incontinence: randomized controlled trials with study quality ratings
TABLE 2.
TABLE 2.:
Comparative effectiveness of surgical treatments for fecal incontinence: observational studies with study quality ratings

All of the included RCTs and observational studies had moderate- or high-risk of bias (Appendices 3 and 4), indicating that study quality was low. In addition, few studies examined the same interventions. Given these 2 important weaknesses, the resulting strength-of-evidence ratings were insufficient for all of the surgical interventions.

Sacral Nerve Stimulation

Five crossover RCTs examined SNS, mostly in 55- to 60-year–old women with mixed FI etiologies (Table 1). The evidence for SNS was insufficient because all 5 of the studies had moderate27,36 or high28,29,35 risk of bias, and none assessed the same treatment–outcome combination. Brief RCT summaries are below; details are provided in Table 1 and Appendix Table 3.

The RCTs compared the SNS versus supportive medical care on FI outcomes <1 year.36 Authors reported significant within-group improvements in Cleveland Clinic Fecal Incontinence Score (CCFIS), FI episodes, and Fecal Incontinence Quality of Life with SNS in a single, unblinded RCT. Not all of the collected outcomes were reported, outcomes were assessed by the investigators, and between-group statistical comparisons were not conducted.

RCTs also compared the effects of leaving the SNS stimulator on versus off for 1 month on FI frequency and the CCFIS.29 There was no significant difference in CCFIS improvement between on versus off periods; graphical FI episode counts were not usable.

Stimulation at 75% or 50% of sensory threshold versus stimulation at sensory threshold (ST) in adults using SNS for ≥3 months at study enrollment was also compared.27 No significant change in CCFIS, Vaizey score, or other FI functional outcomes occurred across SNS settings; the Fecal Incontinence Quality of Life coping subscale improved at sensory threshold only.

High-frequency, low, or prolonged pulse width stimulation to regain efficacy in persons with sustained loss of efficacy after chronic stimulation was compared.35 The CCFIS modestly improved (–2.4 to –2.7 points) during the 4-week RCT segments with high frequency or prolonged pulse width stimulation, but no other outcomes were significantly or meaningfully improved.

Finally, turning stimulation off versus leaving it on at night on FI outcomes was compared.28 The CCFIS and Vaizey scores were 1 point worse during the off at night period in a crossover study without any washout period, and no baseline values were reported for any outcome measure.

Two high risk-of-bias observational studies (Table 2 and Appendix Table 4) provided insufficient evidence for SNS versus sphincteroplasty40 and for open versus percutaneous SNS lead placement.41 Follow-up between groups differed by >2 years in both studies (Table 2).

Sphincteroplasty

Anal sphincter repair was examined in 2 RCTs31,37 and 5 observational studies.40,42–45 There was insufficient RCT evidence (Table 1) to compare the effectiveness of sphincter repair with stoma/fecal diversion versus sphincter repair alone37 from 1 high risk-of-bias RCT that assessed CCFIS changes from baseline anywhere from 16 to 47 months postoperatively and did not report mean follow-up by group (Table 1). There was also insufficient RCT evidence to compare the effectiveness of adjuvant biofeedback after anal sphincter repair versus sphincter repair alone31 in 1 high risk-of-bias RCT. Improvements in CCFIS, Fecal Incontinence Quality of Life subscale, and patient satisfaction were not significantly different by group. Authors excluded postrandomization data from 18% of the sample (Table 1).

Observational studies (Table 2) provided insufficient evidence to compare the effectiveness of a perineal versus posterior fourchette incision in overlapping anal sphincter repair,42 sphincteroplasty with pelvic floor repair versus sphincteroplasty,43 sphincteroplasty versus SNS,40 sphincteroplasty versus anterior levatorplasty,44 and direct versus anterior sphincter repair.45 Four40,43–45 of these 5 studies had high risk of bias (Appendix Table 4).

Anal Sphincter Replacement

Given the strength of evidence grading criteria listed in the Patients and Methods section above, evidence was insufficient to compare the effectiveness of an artificial bowel sphincter (ABS) versus conservative medical management from 1 high risk-of-bias RCT of 14 patients with severe FI32 (Table 1 and Appendix Table 3) and from 1 high risk-of-bias observational study of a non-US Food and Drug Administration–approved magnetic anal sphincter versus an ABS46 (Table 2 and Appendix Table 4).

Other Surgeries and Mixed Treatment Comparisons

Evidence was also insufficient to compare the effectiveness of total pelvic floor repair versus gluteus maximus transposition without electrical stimulation for postobstetric neuropathic FI,38 postanal repair versus total pelvic floor repair for neurogenic FI,34 and total pelvic floor repair versus anterior levatorplasty versus postanal repair for neurogenic FI39 (Table 1).

For mixed treatments, evidence was insufficient for levatorplasty versus nonsurgical anal plug electrostimulation33 from 1 high risk-of-bias RCT, with differential losses to follow-up by group (13% vs 25%) and exclusion of noncompleters from the analysis (Table 1); for nonsurgical percutaneous posterior tibial nerve stimulation compared with SNS30 that excluded 23% of postrandomization data from the analysis(Table 1); and for the magnetic anal sphincter versus SNS,47 where follow-up differed by 16 months between groups (Table 2).

Evidence was insufficient for recommendations after failed sphincteroplasty.13 Only 1 high risk-of-bias observational study compared the outcomes of 3 surgical treatments used in adults who had failed at least 1 previous sphincteroplasty13 (Table 2).

Adverse Effects

Adverse effects from surgical treatments were reported in 8 RCTs (Table 3), 8 observational studies with comparators (Table 4), and 53 case series (Appendix Table 5). Surgical complications were common and ranged from minor (eg, swelling or hematoma) to major (eg, infection, bowel obstruction, perforation, or fistula); major complications often required reoperation; some required a permanent colostomy. Notably, we found only case series studies for radiofrequency anal sphincter remodeling and antegrade colonic irrigation (ACE) in adults.

TABLE 3.
TABLE 3.:
Adverse effects of surgical treatments for fecal incontinence in randomized controlled trials
TABLE 4.
TABLE 4.:
Adverse effects of surgical treatments for fecal incontinence in observational studies with comparison groups

The frequency of surgical complications (Tables 3 and 4 and Appendix Table 5) ranged from 0% to 32% in radiofrequency anal sphincter remodeling,48–53 21% to 74% in ACE,54–57 5% to 27% with sphincteroplasty,13,37,42–45,58–66 2% to 93% with SNS,13,29,30,36,41,47,67–85 8% to 64% with other surgeries,33,38,39,86 and 22% to 100% with sphincter replacement.13,32,46,87–100

The severity of adverse effects varied by the type of surgery (Tables 3 and 4 and Appendix Table 5). Adverse effects were generally less severe for radiofrequency anal sphincter remodeling (pain, bleeding, swelling, and mucosal ulceration) and SNS (infection, pain, electrode/lead issues, and device malfunction). However, SNS required reoperation in 3% to 41% of patients for device-related complications (Table 4 and Appendix Table 5), and 3% to 24%41,47,67–69,71,72,74–81,85 of patients had the device explanted. ACE, sphincter repair, and sphincter replacement had more severe complications (wound infection, stenosis, bowel obstruction, sepsis, and fistula; Appendix Table 5). The most frequent and severe complications occurred with the ABS; infections were very common, and 14% to 81% of recipients underwent surgical explant of the device; some patients required permanent colostomy.13,32,46,87–100

DISCUSSION

As determined using standard quality assessment criteria, the evidence for surgical treatment effectiveness for FI in adults is insufficient for all surgical interventions. Few surgical procedures were examined in RCTs or observational studies with comparison groups; study aims and treatments were highly varied, and all of the surgical studies had moderate to high risk of bias. The overwhelming majority (71%) of surgical studies reviewed were case series, which provide low-quality research evidence. We were unable to conduct a meta-analysis, because few studies examined the same treatment–outcome combination within similar timeframes, and outcome measures varied. Thus, the literature provides little guidance for surgeons and patients in their selection of surgical treatments for FI.

Study conduct and reporting were often inconsistent with longstanding Consolidated Standards of Reporting Trials (CONSORT) recommendations,101–103 thereby diminishing support for individual study conclusions (Appendix Tables 3 and 4).

Case series of some procedures, such as ACE and sphincter replacement, showed that complications may occur months after surgery (Appendix Table 5). The severity of complications increased with the invasiveness of the treatment. Complications from ACE, sphincteroplasty, and sphincter replacement were most severe; SNS complications were less severe, but all of these treatments may require additional major or minor surgery.

Findings in Relationship to What Is Already Known

We examined the range of surgical treatments available for FI in adults in the United States and included randomized and nonrandomized literature. In contrast, previous systematic reviews examined evidence within single modes of FI treatment, such as surgery or SNS,15,17,18,104 and relied primarily on RCT evidence for adverse effects. Similar to our findings, other systematic reviews found weak evidence for most procedures and similar literature limitations (small number of studies, small patient samples, and substantial methodologic limitations), leaving little definitive evidence in support of specific surgical procedures for FI. However, this review adds substantial information on postoperative complications that is not available from previous systematic reviews.

We compared our findings with recent FI treatment guidelines from 2 professional societies, the American College of Gastroenterology105 and the American Society of Colon and Rectal Surgeons106 (Appendix Table 6). None of the surgical recommendations by the American Society of Colon and Rectal Surgeons or American College of Gastroenterology are supported by the findings of this review. There is general agreement about the weak strength of the evidence but variation in the actions recommended in the face of this situation. One example of this discrepancy is in recommendations for the ABS (Appendix Table 6). The American Society of Colon and Rectal Surgeons gave the ABS a strong (favorable) recommendation,106 yet noted that the evidence for that opinion was of low or very low quality. In contrast, the American College of Gastroenterology identified the ABS evidence as insufficient105 and gave it a weak recommendation105; our review also found the evidence about ABS to be insufficient to enable conclusions about the effectiveness of ABS. Colorectal surgeons more strongly favored surgical approaches than did the gastroenterologists; both groups supported SNS, which had insufficient evidence in this review.

Limitations

Limitations of the evidence base compose the majority of limitations of this review. The evidence base would benefit from better compliance with CONSORT101 and greater efforts to avoid compromising study integrity by analyzing only a subset of randomized adults. Also, although FI is a chronic problem, most surgical evidence of treatment benefits is intermediate term; high-quality, longer-term information would better inform clinical decisions. In addition, common outcome measures need to be standardized. The same scoring system was often referenced by several names. The Vaizey score (0–24107) was sometimes labeled as “St. Mark’s” (0–13108),27,28,35 and the CCFIS109 was labeled as CCFIS, Wexner, or Jorge/Wexner. More information about typical patient demographics, clinical features, and status at enrollment would better inform about which treatments work best in which patients. Information on cointerventions was also limited. More uniformity in how FI episodes are defined and severity graded would improve comparability across studies; clinicians and patients may disagree on FI severity ratings.110 Input from adults with FI may help to identify and quantify aspects of FI that capture outcomes most important to patients, such as urgency. Multiple etiologies may contribute to FI; perhaps as a result, etiologies were variably reported in the literature. No study provided information about the frequency of multiple FI etiologies per adult at baseline, such as summary counts per patient or common etiologic/risk factor combinations.

There are several limitations related to the review process. As stated above, meta-analysis was not possible because treatment–outcome combinations varied. Although this review was limited to English-language publications, the possibility of missing clinical trials of US Food and Drug Administration–approved procedures is remote.111,112 We did not contact authors for clarification of indeterminable information.

Research Gaps

Three steps could advance FI research quality: 1) conduct and report clinical research that in accordance with CONSORT criteria; 2) establish academic research/clinical centers to facilitate a more structured, multidisciplinary team approach to research question development and study design; and 3) enhance patient input into outcome measure development. Validated outcome measures that capture the FI impact features most meaningful to patients (eg, urgency and severity) are critical to advance the field.

Funding mechanisms, such as the P01 or P50 program grants from the National Institutes of Health, could support these clinical research activities. Such centers could be regional centers that do high-volume work in FI or research centers that coordinate multicenter studies, providing strong research designs and assuring fidelity to treatment.

Few if any treatments can entirely cure FI; therefore, information on treatment combinations would benefit the evidence base. More work is needed to determine which additional interventions should be undertaken postoperatively and when they should be initiated to enhance or prolong the durability of surgical benefits.

The sustainability of surgical treatment effects over time deserves more attention. Longer-term studies were largely case series of subsets of adults who underwent procedures and had extended follow-up, leaving many questions about adults who underwent the same procedures but were not included in reporting.

The degree of external anal sphincter defect that impacts the outcome of SNS is unclear. Older studies excluded patients with extensive tears; more recent observational studies found that adults with extensive tears improve with SNS <1 year.113,114

There is limited information about the results of treatments chosen after failed index surgical procedures.13 Better comparison of the benefit:harm ratio of FI treatments is needed, especially for invasive surgical interventions. Substantial and life-altering adverse events occur after FI surgery, and these were underidentified in RCTs.

Implications for Clinical and Policy Decision Making

The current FI literature lacks high-quality research evidence to inform clinical practice or policy. These findings differ from professional society guidelines in several key areas; these groups may wish to re-evaluate treatment recommendations based on weak or insufficient evidence and revise such guidelines. Given the clinical complexity of many adults with FI, potential new centers that could generate better research evidence and manage patients in multidisciplinary settings may be the next best step to advance both research and patient care.

CONCLUSION

The quality of the FI surgical evidence is insufficient for clinical decision making. Substantial methodologic and reporting issues can be rectified by following current study and reporting standards; small improvements could provide higher-quality evidence. The use of numerous outcome measures impedes the field. The overall strength of evidence for treatments for FI in adults was insufficient, suggesting that future studies with higher quality evidence could change the conclusions of this review.

APPENDIX FIGURE 1.
APPENDIX FIGURE 1.:
Flow chart that outlines the citation retrieval and study selection process, starting with the total number of citations retrieved from the fecal incontinence literature searches (top) and ending with the number of included surgical references (bottom).
APPENDIX TABLE 1.
APPENDIX TABLE 1.:
Medline Search Strategies
APPENDIX TABLE 2.
APPENDIX TABLE 2.:
Study inclusion criteria for fecal incontinence reviewa
APPENDIX TABLE 3.
APPENDIX TABLE 3.:
Risk of bias ratingsa for randomized controlled trials of surgical FI treatmentsb
APPENDIX TABLE 4.
APPENDIX TABLE 4.:
Risk of biasa ratings in surgical fecal incontinence observational studies with a comparison groupb
APPENDIX TABLE 5.
APPENDIX TABLE 5.:
Adverse effects reported in case series of surgical procedures for fecal incontinence in adultsa
APPENDIX TABLE 6.
APPENDIX TABLE 6.:
Recommendations from professional society guidelines for surgical treatments for fecal incontinence, compared with findings of this systematic review

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Keywords:

Fecal incontinence; Surgery; Systematic review

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