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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659176
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

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

Condition or disease Intervention/treatment Phase
Rectocele Procedure: Transperineal repair with PIS Procedure: Transperineal repair without PIS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

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Arm Intervention/treatment
Active Comparator: Transperineal repair with PIS
transperineal repair of anterior rectocele with limited internal sphincterotomy
Procedure: Transperineal repair with PIS
Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.

Active Comparator: Transperineal repair without PIS
transperineal repair of anterior rectocele only
Procedure: Transperineal repair without PIS
Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy




Primary Outcome Measures :
  1. Incidence of recurrence [ Time Frame: 18 months ]
    Number of patients presenting with recurrent or persistent symptoms during follow up



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659176


Locations
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Egypt
Mansoura university hospital
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed Youssef, M.D Mansoura Univesity
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Responsible Party: Sameh Emile, Lecturer of surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT02659176    
Other Study ID Numbers: mansoura31
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rectocele
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia
Pathological Conditions, Anatomical