Transvaginal Versus Transperineal Repair of Rectocele

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-01-07

Brief Summary

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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

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Detailed Description

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Conditions

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Rectocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transvaginal repair

Repair of anterior rectocele via the vagina

Group Type ACTIVE_COMPARATOR

Transvaginal repair

Intervention Type PROCEDURE

Vaginal incision through which plication of the rectovaginal septum is done

Transperineal repair

Repair of anterior rectocele via the perineum

Group Type ACTIVE_COMPARATOR

Transperineal repair

Intervention Type PROCEDURE

Perineal incision through which plication of the rectovaginal septum is done

Interventions

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Transvaginal repair

Vaginal incision through which plication of the rectovaginal septum is done

Intervention Type PROCEDURE

Transperineal repair

Perineal incision through which plication of the rectovaginal septum is done

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No