Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

NCT ID: NCT04502953

Last Updated: 2020-08-06

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-05-30

Brief Summary

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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.

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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Vertical plication

Vertical plication of the rectovaginal septum was done

Group Type ACTIVE_COMPARATOR

Vertical plication

Intervention Type PROCEDURE

Vertical plication of the rectovaginal septum was done

Horizontal plication

Horizontal plication of the rectovaginal septum was done

Group Type ACTIVE_COMPARATOR

Horizontal plication

Intervention Type PROCEDURE

Horizontal plication of the rectovaginal septum was done

Interventions

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Vertical plication

Vertical plication of the rectovaginal septum was done

Intervention Type PROCEDURE

Horizontal plication

Horizontal plication of the rectovaginal septum was done

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sameh H Emile

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mansoura20201

Identifier Type: -

Identifier Source: org_study_id

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