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ACTIVE NOT RECRUITING
NCT06804993
PHASE4

Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial

Sponsor: Mansoura University

View on ClinicalTrials.gov

Summary

This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-07-31

Completion Date

2025-03-31

Last Updated

2025-02-03

Healthy Volunteers

No

Interventions

DRUG

Transvaginal repair & botulinum toxin type A injection

100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)

PROCEDURE

Transvaginal repair & distilled water injection

A total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)

Locations (1)

Mansoura University Hospital

Al Mansurah, Egypt