Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele

NCT ID: NCT02659176

Last Updated: 2016-03-16

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-02-29

Brief Summary

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Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

Detailed Description

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Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.

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 Caregivers Investigators

Study Groups

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Transperineal repair with PIS

transperineal repair of anterior rectocele with limited internal sphincterotomy

Group Type ACTIVE_COMPARATOR

Transperineal repair with PIS

Intervention Type PROCEDURE

Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.

Transperineal repair without PIS

transperineal repair of anterior rectocele only

Group Type ACTIVE_COMPARATOR

Transperineal repair without PIS

Intervention Type PROCEDURE

Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy

Interventions

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Transperineal repair with PIS

Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.

Intervention Type PROCEDURE

Transperineal repair without PIS

Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with anterior rectocele

Exclusion Criteria

* Pregnant females
* Rectocele with pelvic organ prolapse
* Any patient with previous anorectal surgery
* Pudendal nerve neuropathy
* Anal fistula and sepsis
* Patients with sphincter defect proved by endo-anal sonography
* Patients proved to have colonic inertia either by colon transit time and/or history
* Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
* Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Youssef, M.D

Role: PRINCIPAL_INVESTIGATOR

Mansoura Univesity

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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mansoura31

Identifier Type: -

Identifier Source: org_study_id

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