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

Not Applicable

Completed

• Conditions: Obstructed Defecation; Anismus; Constipation
• Interventions: Other: BFD; Other: BTX A; Procedure: PDPR

• Registration Number: NCT00735605
• Lead Sponsor: Mansoura University

Brief Summary

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

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1:BFD	BFD	The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
2 BTX A	BTX A	Injected with BTX-A in the left lateral position; anesthesia was not required
3: PDPR	PDPR	Inner half of puborectalis sling was divided on each side by using a scalpel NO

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ayman Elnakeeb; 🇪🇬 Mansoura, Egypt