Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients

Study Overview
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Brief Summary
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Comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation. Anismus is a significant cause of chronic constipation. This study came to compare the results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients. Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional constipation were included in this study. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the EAS. All patients had non relaxing puborectalis muscle.. The patients were randomized into three groups. Group I patients received biofeedback therapy, two times per week for about 1 month. Group II patients were injected with BTX- A. Group 111 partial division of puborectalis was done. Follow up was conducted weekly in the first month then monthly for about 1 year.

Detailed Description
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Key words: Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Official Title
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Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation

Conditions
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Obstructed Defecation, Anismus, Constipation

Intervention / Treatment
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* Other: BFD
* Procedure: PDPR
* Other: BTX A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60patients fulfilled Rome II criteria for functional constipation All patients were unresponsive to laxatives or enema use Exclusion Criteria: Pregnant patients Patients with sphincteric defect Any patient proved to have colonic inertia by colon transit time Any patient with previous history of pelvic surgery e.g. mesh rectopexy Duhamel operation were excluded

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1:BFD<br>The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip | Other: BFD<br>* The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip<br>* Other names: BIOFEEDBACK RETRAINING;|
| Active Comparator: 2 BTX A<br>Injected with BTX-A in the left lateral position; anesthesia was not required | Other: BTX A<br>* A vial of Dysport, 500 u, (Dysport, Ipsen, United Kingdom) is dissolved in 2.5 ml isotonic saline Fig(1). A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient<br>* Other names: BOTILINUM TOXIN;|
| Active Comparator: 3: PDPR<br>Inner half of puborectalis sling was divided on each side by using a scalpel NO | Procedure: PDPR<br>* A 2-3 cm curved incision is made on either side of the anal canal along its posterolateral aspect, each about 2.5 cm distance from the anal verge Fig(2). After that dissection in ischiorectal fossa was done till reaching the puborectalis sling from outside i.e. extrasphincteric approach . Using a right angle forceps the puborectalis sling is lifted up, guided by the contralateral index finger in the anal canal Fig(3). Nearly the inner half of puborectalis sling was divided on each side by using a scalpel NO. 11 Fig(4). Complete haemostasis was followed by skin closure without drain<br>* Other names: PARTIAL DIVISION OF PUBORECTALIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in bowel habit (regarding the straining severity, anorectal pain,number of weakly bowel movement,sensation of incomplete defecation and need of digitation or enema and using constipation score) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructed defecation, constipation, puborectalis