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NCT04502953 Clinical Trial

Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

Rectocele Clinical Trial

Official title:
Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04502953
Other study ID # Mansoura20201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date May 30, 2020

Study information
Verified date August 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 30, 2020
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Vertical plication of the rectovaginal septum was done

Exclusion Criteria:

- patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse

- patients with slow transit constipation.

- patients with recurrent rectocele after previous surgery.

- patients with pre-existing FI

- patients with associated anorectal pathology.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Vertical plication
Vertical plication of the rectovaginal septum was done
• Horizontal plication
Horizontal plication of the rectovaginal septum was 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 Complete cure of symptoms Absence of symptoms of constipation with Wexner score <2 12 months after repair
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