Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT04502953

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rectocele	Procedure: Vertical plication Procedure: Horizontal plication	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

May 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vertical plication Vertical plication of the rectovaginal septum was done	Procedure: Vertical plication Vertical plication of the rectovaginal septum was done
Active Comparator: Horizontal plication Horizontal plication of the rectovaginal septum was done	Procedure: Horizontal plication Horizontal plication of the rectovaginal septum was done

Arm

Intervention/Treatment

Active Comparator: Vertical plication

Vertical plication of the rectovaginal septum was done

Procedure: Vertical plication

Vertical plication of the rectovaginal septum was done

Active Comparator: Horizontal plication

Horizontal plication of the rectovaginal septum was done

Procedure: Horizontal plication

Horizontal plication of the rectovaginal septum was done

Outcome Measures

Primary Outcome Measures

Complete cure of symptoms [12 months after repair]
Absence of symptoms of constipation with Wexner score <2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansourah	Dakahlia	Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Study Chair: Sameh H Emile, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT04502953

Other Study ID Numbers:

Mansoura20201

First Posted:

Aug 6, 2020

Last Update Posted:

Aug 6, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectocele

Study Results

No Results Posted as of Aug 6, 2020