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NCT03801291 Clinical Trial

Transvaginal Versus Transperineal Repair of Rectocele

Rectocele Clinical Trial

Official title:
Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03801291
Other study ID # masnoura99
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2016
Est. completion date January 7, 2019

Study information
Verified date January 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date January 7, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Adult female patients with anterior rectocele

Exclusion Criteria:

- Male patients.

- Combined rectocele with internal rectal prolapse.

- Anismus.

- Associated anorectal condition such as hemorrhoids and anal fissure.

- Pregnancy.

- Unwilling to participate in the trial

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transvaginal repair
Vaginal incision through which plication of the rectovaginal septum is done
• Transperineal repair
Perineal incision through which plication of the rectovaginal septum is done

Locations
Country Name City State
Egypt Mansoura university hospital Mansourah Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in constipation decrease in Wexner constipation score by 25% 6 and 12 months after surgery
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