NCT00735605

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obstructed Defecation
• Anismus
• Constipation

Interventions

Type	Name	Description
OTHER	BFD	The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
PROCEDURE	PDPR	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
OTHER	BTX A	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

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-08-15
• Last updated: 2010-01-13

Locations

1 site across 1 country: Egypt