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## Complete Summary

#### GUIDELINE TITLE

Practice parameters for the treatment of fecal incontinence.

#### BIBLIOGRAPHIC SOURCE(S)

Tjandra JJ, Dykes SL, Kumar RR, Ellis CN, Gregorcyk SG, Hyman NH, Buie
WD, Standards Practice Task Force of The American Society of Colon and
Rectal Surgeons. Practice parameters for the treatment of fecal
incontinence. Dis Colon Rectum 2007 Oct;50(10):1497-507. \[132
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17674106)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Fecal incontinence (including incontinence of flatus)

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Treatment

#### CLINICAL SPECIALTY

Colon and Rectal Surgery\
Family Practice\
Gastroenterology\
Geriatrics\
Internal Medicine

#### INTENDED USERS

Health Care Providers\
Patients\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide practice parameters for the treatment of fecal incontinence

#### TARGET POPULATION

Adults with fecal incontinence

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Evaluation**

Severity (type, frequency, and amount of incontinence) and impact
(quality of life) assessments using reliable and validated grading and
summary scales

**Diagnosis**

1.  History and physical examination (including inspection of perianal
    skin, Valsalva maneuver, digital examination, anoscopy, flexible
    sigmoidoscopy)

2.  Endoanal ultrasound

3.  Anorectal physiology studies (anal manometry)

**Treatment**

*Nonoperative*

1.  Increased fiber intake

2.  Antidiarrheal agents (adsorbents, opium derivatives)

3.  Enemas, laxatives, and suppositories

4.  Biofeedback

5.  Anal plug

*Surgical Options*

1.  Sphincter repair (overlapping, direct, and repeat)

2.  Internal anal sphincter (IAS) repair alone (considered but not
    generally recommended)

3.  Injectable therapy (silicone biomaterial, carbon-coated beads)

4.  Sacral nerve stimulation (SNS) (not approved for fecal incontinence
    by the US Food and Drug Administration \[FDA\])

5.  Post anal repair or total pelvic floor repair

6.  Dynamic graciloplasty (not approved by the FDA)

7.  Artificial bowel sphincter

8.  Delivery of temperature-controlled radiofrequency energy to the anal
    canal (SECCA procedure)

9.  Stoma (colostomy or ileostomy)

#### MAJOR OUTCOMES CONSIDERED

-   Response rate to treatment

-   Duration of response

-   Quality of life

-   Recurrence rate of symptoms of fecal incontinence following
    treatment

-   Wound healing and complications rates from surgery

-   Sensitivity and specificity of diagnostic tools

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A MEDLINE search was performed, from 1966 to February 2006, using the
key words \"fecal incontinence,\" \"anus,\" \"implants,\" \"bowel
sphincter,\" \"graciloplasty,\" and \"artificial sphincter.\" Selected
embedded references also were reviewed. The Cochrane Database of
Systematic Reviews was queried.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

I.  Meta-analysis of multiple well-designed, controlled studies,
    randomized trials with low false-positive and low false-negative
    errors (high power)

II. At least one well-designed experimental study; randomized trials
    with high false-positive or high false-negative errors or both (low
    power)

III. Well-designed, quasi-experimental studies, such as nonrandomized,
     controlled, single-group, preoperative-postoperative comparison,
     cohort, time, or matched case-control series

IV. Well-designed, nonexperimental studies, such as comparative and
    correlational descriptive and case studies

V.  Case reports and clinical examples

Adapted from Cook DJ, Guyatt GH, Laupacis A, Sackett DL. Rules of
evidence and clinical recommendations on the use of antithrombotic
agents. Chest 1992;102(4 Suppl):305S--11S. Sacker DL. Rules of evidence
and clinical recommendations on the use of antithrombotic agents. Chest
1989;92(2 Suppl):2S--4S.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grades of Recommendations**

A.  Evidence of Type I or consistent findings from multiple studies of
    Type II, III, or IV

B.  Evidence of Type II, III, or IV and generally consistent findings

C.  Evidence of Type II, III, or IV but inconsistent findings

D.  Little or no systematic empirical evidence

Adapted from Cook DJ, Guyatt GH, Laupacis A, Sackett DL. Rules of
evidence and clinical recommendations on the use of antithrombotic
agents. Chest 1992;102(4 Suppl):305S--11S. Sacker DL. Rules of evidence
and clinical recommendations on the use of antithrombotic agents. Chest
1989;92(2 Suppl):2S--4S.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The levels of evidence (**I-V**) and the grades of recommendations
(**A-D**) are defined at the end of the \"Major Recommendations\" field.

**Assessment**

1.  Evaluation of fecal incontinence should include consideration of
    severity and impact. **Level of Evidence: Class II; Grade of
    Recommendation: B**

> Severity instruments assess type, frequency, and amount of
> incontinence. Impact questionnaires address quality of life and
> attempt to evaluate the effect of incontinence on emotional,
> occupational, physical, and social function. Both should evaluate
> these relatively subjective factors with reliability and validity.

**Diagnosis**

1.  A problem-specific history and physical examination should be
    performed. **Level of Evidence: Class V; Grade of Recommendation:
    D.**

> A detailed medical history may help to elicit contributing or
> exacerbating factors, such as gastrointestinal or neurologic
> disorders. An obstetric account or history of previous anorectal
> surgery or perineal trauma can direct/prompt a more focused
> examination.
>
> Inspection of the perianal skin may reveal excoriation, surgical
> scars, or fistulas, and the anus may be noted to gape upon spreading
> the buttocks. Mucosal or full-thickness prolapse may be elicited with
> a Valsalva maneuver. Digital examination may provide a rough estimate
> of resting and squeeze pressures and is helpful to evaluate for a
> rectal mass or the presence of impacted stool, which would suggest
> overflow as a possible mechanism for incontinence. Anoscopy and
> flexible sigmoidoscopy may help to identify hemorrhoids, inflammatory
> bowel disease, or neoplasms.

2.  Endoanal ultrasound is usually the procedure of choice to diagnose
    sphincter defects in patients with suspected sphincter injury.
    Anorectal physiology studies may be helpful in guiding management.
    **Level of Evidence: Class II; Grade of Recommendation: B.**

**Nonoperative Treatment**

1.  A trial of increased fiber intake is recommended in milder forms of
    fecal incontinence to improve symptoms. **Level of Evidence: III;
    Grade of Recommendation: B.**

> Nonoperative therapy is usually the first maneuver to improve the
> symptoms of fecal incontinence. Most patients with mild fecal
> incontinence should usually receive an initial trial of nonoperative
> management.
>
> Gradual increase of fiber intake during a period of several days can
> reduce symptoms, such as abdominal bloating and discomfort that may be
> associated with increased fiber intake. Fiber supplements in the form
> of powder, granule, or pill often facilitate this goal. Dairy products
> are problematic in patients with lactose intolerance.

2.  Antidiarrheal agents, such as adsorbents or opium derivatives, may
    reduce fecal incontinence symptoms. **Level of Evidence: III; Grade
    of Recommendation: C.**

> Adsorbents, such as kaopectate (Pharmacia & Upjohn, Peapack, NJ), act
> by absorbing excess fluid in the stool. Commonly used opium
> derivatives are loperamide (Imodium, McNeil Consumer Healthcare, Fort
> Washington, PA), diphenoxylate hydrochloride plus atropine sulphate
> (Lomotil, Searle, Chicago, IL), codeine, and tincture of opium.

3.  Enemas, laxatives, and suppositories may help to promote more
    complete bowel emptying in appropriate patients and minimize further
    postdefecation leakage. **Level of Evidence: V; Grade of
    Recommendation: D.**

> Evaluation and management of abnormal colonic transit also can be
> helpful.

4.  Biofeedback is recommended as an initial treatment for motivated
    patients with incontinence with some voluntary sphincter
    contraction. **Level of Evidence: III; Grade of Recommendation: B.**

> Biofeedback may be considered a first-line option for many patients
> with fecal incontinence who have not responded to simple dietary
> modification or medication.
>
> Supportive counseling and practical advice regarding diet and skin
> care can improve the success of biofeedback. Biofeedback may be
> considered before attempting sphincter repair or for those who have
> persistent or recurrent symptoms after sphincter repair. It may have a
> role in the early postpartum period in females with symptomatic
> sphincter weakness. Biofeedback and a pelvic floor exercise program
> can produce improvement that lasts more than two years.
>
> Biofeedback home training is an alternative to ambulatory training
> programs, especially in the elderly.

5.  An anal plug is effective in controlling fecal incontinence in a
    small minority of patients who can tolerate its use. **Level of
    Evidence: V; Grade of Recommendation: D**

**Surgical Options**

1.  Sphincter repair is appropriately offered to highly symptomatic
    patients with a defined defect of the external anal sphincter.
    **Level of Evidence: II; Grade of Recommendation: A**.

2.  Overlapping or direct sphincter repair yield similar results, as
    long as adequate mobilization of both ends of the sphincters are
    performed. **Level of Evidence: II; Grade of Recommendation: A.**

3.  Repeat anal sphincter repair could be considered in patients who
    have recurrent symptoms and residual anterior sphincter defect after
    a previous sphincter repair. **Level of Evidence: III; Grade of
    Recommendation: B.**

4.  Repair of the internal anal sphincter alone has a poor functional
    outcome and is not generally recommended. **Level of Evidence: III;
    Grade of Recommendation: B**.

5.  When passive fecal incontinence caused by internal sphincter
    dysfunction is the predominant symptom, injectable therapy seems to
    be effective and safe, although its long-term efficacy has yet to be
    defined. **Level of Evidence: II; Grade of Recommendation: B.**

6.  Sacral nerve stimulation (SNS) is a promising modality for fecal
    incontinence. **Level of Evidence: III; Grade of Recommendation:
    B.**

7.  Postanal repair or total pelvic floor repair has a limited role in
    the treatment of neuropathic fecal incontinence. **Level of
    Evidence: III; Grade of Recommendation: B.**

8.  Dynamic graciloplasty may have a role in the treatment of severe
    fecal incontinence when there is irreparable sphincter disruption.
    **Level of Evidence: III; Grade of Recommendation: B.**

9.  The artificial bowel sphincter has a role in the treatment of severe
    fecal incontinence, especially in patients with significant
    sphincter disruption. **Level of Evidence: III; Grade of
    Recommendation: B.**

10. The SECCA (safety and effectiveness of temperature-controlled
    radio-frequency energy delivery to the anal canal) procedure may be
    useful for selected patients with moderate fecal incontinence.
    **Level of Evidence: IV; Grade of Recommendation: C.**

> The SECCA procedure consists of the delivery of temperature-controlled
> radiofrequency energy to the anal sphincters. It is believed that the
> heat generated causes collagen contraction, healing, and remodeling,
> leading to shorter and tighter muscle fibers.

11. A stoma (colostomy or ileostomy) is appropriate for patients with
    limiting fecal incontinence in which available treatments have
    failed, are inappropriate because of comorbidities, or when
    preferred by the patient. **Level of Evidence: III; Grade of
    Recommendation: B.**

**[Definitions]{.underline}**:

**Levels of Evidence**

I.  Meta-analysis of multiple well-designed, controlled studies,
    randomized trials with low false-positive and low false-negative
    errors (high power)

II. At least one well-designed experimental study; randomized trials
    with high false-positive or high false-negative errors or both (low
    power)

III. Well-designed, quasi-experimental studies, such as nonrandomized,
     controlled, single-group, preoperative-postoperative comparison,
     cohort, time, or matched case-control series

IV. Well-designed, nonexperimental studies, such as comparative and
    correlational descriptive and case studies

V.  Case reports and clinical examples

**Grades of Recommendations**

A.  Evidence of Type I or consistent findings from multiple studies of
    Type II, III, or IV

B.  Evidence of Type II, III, or IV and generally consistent findings

C.  Evidence of Type II, III, or IV but inconsistent findings

D.  Little or no systematic empirical evidence

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Improvement in symptoms of fecal incontinence

-   Improved quality of life

#### POTENTIAL HARMS

-   Diphenoxylate can produce central nervous system (CNS) side effects
    and has greater potential for abuse.

-   Tincture of opium is less commonly used because of the potential for
    CNS side effects and addiction.

-   Most patients do not tolerate the anal plug because of discomfort.

-   Severe denervation and pudendal nerve damage often are found in
    patients who remain incontinent after a sphincter repair.
    Dyspareunia might follow sphincteroplasty, although the true
    incidence has not been well documented.

-   In one study, island anoplasty into an area of internal anal
    sphincter defect was associated with a high incidence of wound
    breakdown.

-   Silicone biomaterial injected into the submucosa is more likely to
    be associated with infection, erosions of implants, or anal pain
    caused by the superficial location of the injected material compared
    to injection into the intersphincteric plane.

-   The incidence of complications with sacral nerve stimulation (SNS)
    ranges from 5 to 26 percent in various studies.

-   In one study, the explantation rate for artificial bowel sphincter
    was 20 to 37 percent. In a multicenter cohort study, a total of 384
    device-related or potentially device-related adverse events were
    reported in 112 enrolled patients. Revisional surgery was required
    in 46 percent of patients. A lack of sensation for evacuation has
    been reported.

-   Complications of temperature-controlled radiofrequency energy to the
    anal canal (the SECCA procedure) included mucosal ulcers and delayed
    bleeding.

-   A stoma may be associated with significant psychosocial issues and
    stoma-related complications.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Absolute contraindications for an artificial bowel sphincter include
active perineal sepsis, Crohn\'s disease, radiation proctitis, severe
scarring in the perineum, or anoreceptive intercourse.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines are inclusive, and not prescriptive. Their purpose
    is to provide information on which decisions can be made, rather
    than dictate a specific form of treatment.

-   It should be recognized that these guidelines should not be deemed
    inclusive of all proper methods of care or exclusive of methods of
    care reasonably directed to obtaining the same results. The ultimate
    judgment regarding the propriety of any specific procedure must be
    made by the physician in light of all of the circumstances presented
    by the individual patient.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Tjandra JJ, Dykes SL, Kumar RR, Ellis CN, Gregorcyk SG, Hyman NH, Buie
WD, Standards Practice Task Force of The American Society of Colon and
Rectal Surgeons. Practice parameters for the treatment of fecal
incontinence. Dis Colon Rectum 2007 Oct;50(10):1497-507. \[132
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17674106)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007 Oct

#### GUIDELINE DEVELOPER(S)

American Society of Colon and Rectal Surgeons - Medical Specialty
Society

#### SOURCE(S) OF FUNDING

American Society of Colon and Rectal Surgeons

#### GUIDELINE COMMITTEE

Standards Practice Task Force of The American Society of Colon and
Rectal Surgeons

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Joe J. Tjandra, MD; Sharon L. Dykes, MD; Ravin R. Kumar, MD;
C. Neal Ellis, MD; Sharon G. Gregorcyk, MD; Neil H. Hyman, MD; W. Donald
Buie, MD

*Task Force Members*: Gary D. Dunn, MD; Phillip R. Fleshner, MD;
Clifford Y. Ko, MD; David H. Levien, MD; Richard L. Nelson, MD; Graham
L. Newstead, MD; Charles P. Orsay, MD; Paul C. Shellito, MD; Charles A.
Ternent, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Society of Colon and Rectal Surgeons Web
site](http://www.fascrs.org/gedownload!/Fecal Incontinence Practice Parameter.pdf?item_id=418004&version_id=418005).

Print copies: Available from the ASCRS, 85 W. Algonquin Road, Suite 550,
Arlington H eights, Illinois 60005.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on July 7, 2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

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Date Modified: 11/3/2008