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

Mansoura University

Status: Completed

Conditions: Anismus; Obstructed Defecation; Constipation

Treatments: Procedure: PDPR; Other: BFD; Other: BTX A

Study type: Interventional

Funder types: Other

Identifiers

NCT00735605

anismus surgical and non

Details and patient eligibility

About

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.

Full description

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Enrollment: 60 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

1:BFD

Active Comparator group

Description:

The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip

Treatment:

Other: BFD

2 BTX A

Active Comparator group

Description:

Injected with BTX-A in the left lateral position; anesthesia was not required

Treatment:

Other: BTX A

3: PDPR

Active Comparator group

Description:

Inner half of puborectalis sling was divided on each side by using a scalpel NO

Treatment:

Procedure: PDPR