Transvaginal Versus Transperineal Repair of Rectocele

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT03801291

Collaborator

(none)

Enrollment

Location

Arms

33.2

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Rectocele	Procedure: Transvaginal repair Procedure: Transperineal repair	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jan 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transvaginal repair Repair of anterior rectocele via the vagina	Procedure: Transvaginal repair Vaginal incision through which plication of the rectovaginal septum is done
Active Comparator: Transperineal repair Repair of anterior rectocele via the perineum	Procedure: Transperineal repair Perineal incision through which plication of the rectovaginal septum is done

Arm

Intervention/Treatment

Active Comparator: Transvaginal repair

Repair of anterior rectocele via the vagina

Procedure: Transvaginal repair

Vaginal incision through which plication of the rectovaginal septum is done

Active Comparator: Transperineal repair

Repair of anterior rectocele via the perineum

Procedure: Transperineal repair

Perineal incision through which plication of the rectovaginal septum is done

Outcome Measures

Primary Outcome Measures

Improvement in constipation [6 and 12 months after surgery]
decrease in Wexner constipation score by 25%

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Sameh H Emile, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sameh Emile, Lecturer of general surgery, Mansoura University

ClinicalTrials.gov Identifier:

NCT03801291

Other Study ID Numbers:

masnoura99

First Posted:

Jan 11, 2019

Last Update Posted:

Jan 11, 2019

Last Verified:

Jan 1, 2019

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 Jan 11, 2019