Consensus statement AIGO/SICCR diagnosis and treatment of chronic constipation and obstructed defecation (Part II: Treatment)

Bove A, Bellini M, Battaglia E, et al. World J Gastroenterol. 2012 September 28;18(36):4994-5013. Focusing on biofeedback treatment/”Rehabilitative Treatment”

AIGO: Italian Association of Hospital Gastroenterologists

SICCR: Italian Society of Colo-Rectal Surgery

Laura Scheufele PT, DPT, WCS

August 5, 2014

Background from Consensus statement AIGO/SICCR: Diagnosis and treatment of chronic constipation and obstructed defecation (part I: Diagnosis)

The Joint Committee AIGO/SICCR is made up of members of these two scientific societies, elected on the basis of their experience in treating functional and organic problems of the colon and rectum.

Objective of the committee:  To develop a consensus statement on the most important diagnostic and therapeutic aspects of functional constipation and obstructed defecation, including a set of graded recommendations based on a review of the literature and on evidence-based medicine.

Method:

Search :

• Online databases of PUBMED, MEDLINE and COCHRANE

• Articles published in English before April 2011: adult and constipation

            - Definition of primary functional constipation used as outlined in Rome III criteria.

• Key areas identified and then divided into subsections.

-Subsections researched by one or more members of the committee in accordance to preset parameters

-Face-to-face meetings for consensus on the level of evidence and grading of recomendations

 Definitions of Level of Evidence and Grading of recommendations

In accordance with the criteria adopted by the American College of Gastroenterology’s Chronic Constipation Task Force published in 2005.

Medical and Rehabilitative Treatment

Behavioral Modification/Lifestyle Recommendations

“Behavioral modification” is considered to be the first-line treatment in patients with symptomatic chronic constipation.

Physical Exercise:

•Epidemiological studies report constipation more frequent in subjects with a sedentary lifestyle. •Physical activity can increase colonic transit time and reduce other symptoms of constipation in “elderly” subjects (De Schryver)

•Trials evaluating the effect of exercise in constipated patients lacking

•Although increased physical activity is often recommended there is no real evidence that constipation can be improved by physical activity.

Defecation habits:

•Recommendations often made to defecate when the need is felt and to try to defecate at the same time each day, ideally upon awakening and after meals, when the colonic motor activity is highest.

•Heaton et al observed people with normal colonic activity tended to defecated at same time of day, however research also lacking that evaluates these recommendations

Increased fluid intake:

•Trials evaluating the effect of increased liquid in constipation patients is lacking

•No evidence that constipation improves with increased intake unless the patient is dehydrated.

Behavioral modifications are only supported by Level V evidence, Grade C recommendation

Rehabilitative Treatment (RT)

RT aims to improve defecation-related behavior and restore a normal pattern of defecation with both instruments and educational devices. ES, kinesitherapy biofeedback and volumetric rehabilitation can be used in various combinations to correct dys-synergic behavior of abdominal, rectal, and anal sphincter muscles and to improve rectal sensory perception.

“Rehabilitative therapy requires a highly trained therapist and is time-consuming.” Patients must be strongly motivated.

When should RT be prescribed for obstructed defecation?

•Three RCT (Chiarioni G 2006, Heyman S 2007, Rao SS 2007)  noted

•Success rate of approximately 70% and a long-term success rate of approximately 50% (Rao). Level I evidence, Grade A recommendation 

What is the recommended RT for obstructed defecation?

•No universally accepted recommendations for RT

•No specific criteria to evaluate the efficacy of this intervention

•Methods vary greatly including biofeedback, kinesitherapy, electrostimulation, and volumetric rehabilitation and therefore difficult to compare

•Notes some authors combined biofeedback with “kinesitherapy” for the pelvic and perineal muscles

-Aim to teach the correct sequence of contraction and relaxation of the striated muscles required for defecation

-These rehab techniques have not been “codified”, vary greatly and only supported by one  randomized trial (Heyman S 2003).  However this reference may be incorrect as it references a critical review of biofeedback and not a RCT.

Level II evidence, Grade B recommendation

FYI- Pucciani 1998 protocol combining “kinesitherapy” and biofeedback. (reference #102)

1st session: preliminary lesson on relaxed breathing and corporeal consciousness (used at the start of all sessions), diaphragmatic breathing,  marking of perineal area, made easier by peri- and intra-anal digital manipulation, location and focusing of agonist, antagonist and synergic muscles on the perineal plane.

2nd session: antiversion and retroversion pelvic movements, short anal contractions, some exercises of short anal relaxation, perianal and perivaginal stretching,  stretch reflexes of the puborectalis, elicited by the therapist but “contra” a simultaneous voluntary anal contraction.

3rd session: perianal and perivaginal stretching, stretch reflexes of the puborectalis, the learning of abdominal press principles (diaphragm, pelvic floor, abdominal wall, paravertebral muscles, iliopsoas).

4th session: perianal and perivaginal stretching, stretch reflexes of the puborectalis, abdominopelvic synergy (the abdominal press force vectors are directed to the posterior perineum while simultaneous voluntary sphincterial anal relaxation occurs), simulation of defecation by expelling the therapist’s forefinger, but without any abnormal muscular recruitment.

5th session: abdominopelvic synergy and simulation of defecation with slight pelvic floor descent (used from this session until the end of the cycle), consciousness reinforcement with the correct execution of anal relaxation, start of biofeedback (learning of techniques and some exercises regarding anal contractions/relaxation).

6th session: visual control of pelvic floor descent using a mirror, anal corticalization stage: some anal contraction exercises are introduced (bending down, coughing, or the use of Valsalva’s manoeuvre in supine, upright, sitting positions), biofeedback (some exercises of anal relaxation).

7th session: response modulation: gradualness in sphincteric recruitment/inhibition, biofeedback (response modulation).

8th session: response modulation in sphincter inhibition with slight pelvic floor descent, biofeedback (some exercise of anal relaxation with modulation technique).

9th session: revision exercises on abdominopelvic synergy and gradual anal relaxation, biofeedback (revision exercises).

10th session: revision exercises, biofeedback, final interview (stool frequency, laxative-enema assistance)

Rectal hyposensitivity treatment

•Possible goal for RT  to improve rectal sensation when testing has identified rectal hyposensitivity •Treatment involves biofeedback for “sensory retraining” or volumetric rehabilitation using an inflated balloon or water enemas of decreasing volume and a probe to monitor muscle movement.

•No RCT to support either biofeedback or volumetric rehabilitation.

Level IV evidence, Grade C recommendation

Is RT the first therapeutic option?

•Biofeedback generally attempted only after failed pharmacologic therapy

• After drug failure, rehabilitation is the treatment of choice in patients with obstructed defecation

• No adverse side effects

• If  RT fails other treatment options still being viable, including surgery

No rating given

Is RT more effective than drug treatment?

•One RCT showed that biofeedback was superior to laxatives in improving defecation in patients affected by pelvic floor dyssynergia (Chiarioni 2006)

•Authors note laxative dosage was not high in the control group, but finding remains rehabilitation reduced the need for laxatives.

Level 1 evidence, Grade B recommendation

What factors may influence the efficacy of RT?

•No general agreement

• Lau et al (#111) found that comorbid findings on defecography of rectocele, ano-rectal insussusception, descending perineum and or sigmoidocele did not negativey affect the outcomes of biofeedback treatment for paradoxical puborectalis contraction.

Level IV evidence, Grade B recommendation

•Positive predictors: Shim et al, 2011 :harder stools, shorter duration of laxative use, higher recal pressure while straining, and prolonged balloon expulsion independently predicted a positive outcome for RT

Level III evidence, Grade C recommendation

•Negative predictors: Significant anatomic damage, severe psychiatric or neurological disease, poor patient compliance, and poor patient –physiotherapist interactions obstacles to successful treatment.

Level III evidence, Grade C recommendation

Does surgery make RT superfluous?

•NO!

• Experience suggests if satisfactory function not achieved with RT, pelvic floor muscle tone and coordination can still be improved, and thus potentially add to a positive outcome with ano-rectal surgery.

Level V evidence, Grade C recommendation

How should patients who do not respond to RT be managed?

•Generally not clear: no universally accepted set of criteria regarding response to RT exists

•If clinical grounds present for referral (presence of dyssynergic defecation and/or inadequate propulsive forces), and no negative predictive factors present-failure to respond should raise suspicion of significant organic damage and lead to referral for surgical evaluation. 

•Failure to respond to RT is a prerequisite for surgery to correct rectocele and/or ano-rectal intussusception. 

Level II evidence, Grade C recommendations

Should RT be prescribed before or after ano-rectal surgery?

•Generally accepted to begin with RT and if fails then consider surgery

Level II evidence, Grade B recommendation

•No clear guidelines whether to follow RT then surgery, or RT-surgery-RT

-Thought that if surgery unsatisfactory a referral to RT appropriate.

-If patients go directly to surgery secondary to larger anatomic dysfunctions (ie large rectoceles, fissures, etc), to refer afterwards.

Level V evidence, Grade C recommendation.

•RT has been shown to be effective in treating persisting symptoms after the STARR procedure, hemorrhoidectomy, and surgery for mucosal rectal prolapse.

Level V evidence, Grade C recommendation 

What are the medium- and long-term effects of RT?

•Lasting improvement noted up to 2 years

Level I evidence, Grade B recommendation

•One report on a small number of patients found that sacral neuromodulation to be effective

Level IV evidence, Grade C recommendation 

Strengths: Easy question format to follow.

Weaknesses: References at times inaccurate or mislabeled. Does not appear to evaluate the strength of the study or assess risk for bias. Does not try to compare protocols. At times confusing.

Questions:

Do you routinely recommended general exercise program for constipated patients. If so do you specify when they should do it, such as before or after a meal?

Are you using best practice if you educate the patients on lifestyle and dietary modifications with the current level of evidence?

Is there any treatment omitted from the categories outlined?

What is your experience with this population in regards to how many sessions are typical, and do you primarily use biofeedback?

Clinically what is predictive to a positive or negative outcome for you?

Additional resources

—  Shim L, Jones M, Prott G, et al. Predictors of outcome of anorectal biofeedback therapy in patients with constipation. Aliment Pharmacol Ther. 2011;33:1245-1251.

—  Gilliland R, Heymen S, Altomare D, et al. Outcome and predictors of success of biofeedback for constipation. Br J Surg. 1997;84(8):1123-6.