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

Primary Purpose

Rectocele

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transperineal repair with PIS
Transperineal repair without PIS
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectocele

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transperineal repair with PIS

Transperineal repair without PIS

Arm Description

transperineal repair of anterior rectocele with limited internal sphincterotomy

transperineal repair of anterior rectocele only

Outcomes

Primary Outcome Measures

Incidence of recurrence
Number of patients presenting with recurrent or persistent symptoms during follow up

Secondary Outcome Measures

Full Information

First Posted
January 15, 2016
Last Updated
March 14, 2016
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02659176
Brief Title
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
Official Title
Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transperineal repair with PIS
Arm Type
Active Comparator
Arm Description
transperineal repair of anterior rectocele with limited internal sphincterotomy
Arm Title
Transperineal repair without PIS
Arm Type
Active Comparator
Arm Description
transperineal repair of anterior rectocele only
Intervention Type
Procedure
Intervention Name(s)
Transperineal repair with PIS
Intervention Description
Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
Intervention Type
Procedure
Intervention Name(s)
Transperineal repair without PIS
Intervention Description
Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy
Primary Outcome Measure Information:
Title
Incidence of recurrence
Description
Number of patients presenting with recurrent or persistent symptoms during follow up
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Youssef, M.D
Organizational Affiliation
Mansoura Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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