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Transperineal Repair of Primary Obstetric Rectovaginal Fistulas

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: NCT04267757
Recruitment Status : Completed
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Tamer Alsaied Alnaimy, Zagazig University

Brief Summary:

Introduction: A rectovaginal fistula (RVF) is an epithelium-lined abnormal tract between the rectum and the vagina and is often a challenging problem for both the patients and to the surgeons. In literature, there is still debate regarding the best treatment options for rectovaginal fistulas.

Aim: To assess the results of the treatment of rectovaginal fistulas with incontinence and impaired anal tonus using fistulectomy, sphincteroplasty with or without bulbocavernosus muscle (Martius) flap.

Materials and Methods: A total of 22 consecutive patients with simple RVFs were included and assigned to transperineal repair. The patients were divided into two groups , group1: with Martius flap; group2: without Martius flap .Postoperatively, patients were followed up for one year at the outpatient clinic or through telephone interviews with specific questionnaires to collect information on the status of fecal control, flatus, or fecal leakage from the vagina.


Condition or disease Intervention/treatment Phase
Recto Vaginal Fistula Procedure: rectovaginal fistula repair with Martius flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transperineal Repair of Primary Obstetric Rectovaginal Fistulas With Fecal Incontinence Using Fistulectomy, Sphincteroplasty and With or Without Bulbocavernosus Muscle Flap:Surgical Pitfalls and Prevention of Recurrence
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: group 1
RVF with Martius flap
Procedure: rectovaginal fistula repair with Martius flap
rectovaginal fistula repair with Martius flap

Experimental: group 2
RVF without Martius flap
Procedure: rectovaginal fistula repair with Martius flap
rectovaginal fistula repair with Martius flap




Primary Outcome Measures :
  1. rectovaginal fistula repair with or without Martius flap [ Time Frame: 1 year ]
    detect recurrence in rectovaginal fistula repair with or without Martius flap



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1- Rectovaginal fistula caused by obstetric problems 2- Female >20 years

Exclusion Criteria:

  1. other causes of rectovaginal fistula as Crohn's disease or malignant fistula
  2. complex and recurrent fistula -

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): NCT04267757


Locations
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Egypt
Tamer Alsaied Alnaimy
Zagazig, Sharkia, Egypt, 055
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: tamer A. alnaimy, MD Zagazig University

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Responsible Party: Tamer Alsaied Alnaimy, assistant professour, Zagazig University
ClinicalTrials.gov Identifier: NCT04267757    
Other Study ID Numbers: zagazig 2
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectovaginal Fistula
Vaginal Fistula
Fistula
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Rectal Fistula
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases