Treatment of Anal Fistulas Advancement Flap (flap)

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01042821
First received: January 5, 2010
Last updated: NA
Last verified: May 2005
History: No changes posted
  Purpose

This study comprises a prospective study of 40 patients with transphincteric anal fistula. The patients were classified into two groups: Group I: Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa, submucosa, and circular muscle layer sutured 1cm below the level of internal opening. Group II: The same as group one but the flap includes only mucosa and submucosa.


Condition Intervention
Anal Fistula
Procedure: partial rectal wall advancement flap
Procedure: mucosal advancement flap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Anal Fistulas by Partial Rectal Wall Advancement Flap or Mucosal Advancement Flap: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • RECURRENCE OF THE FISTULA [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • healing, complication, patient satisfaction [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: partial rectal wall advancement flap
The flap comprised mucosa, submucosa and circular muscle fibers. It is raised from the dentate line and mobilized 4-6 cm cephaled and advanced to the new dendentate line (1 cm below the dentate line) and sutured with absorbable sutures (vicryl; ethicone 3/0). Also the defect is closed with absorbable sutures.
Procedure: partial rectal wall advancement flap
The flap comprised mucosa, submucosa and circular muscle fibers. It is raised from the dentate line and mobilized 4-6 cm cephaled and advanced to the new dendentate line (1 cm below the dentate line) and sutured with absorbable sutures (vicryl; ethicone 3/0). Also the defect is closed with absorbable sutures.
Other Name: Group 1
Active Comparator: Group 2
The flap comprised mucosa, submucosa only
Procedure: mucosal advancement flap
Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa and submucosal layer sutured 1cm below the level of internal opening
Other Name: advancement flap

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with transphincteric anal fistula

Exclusion Criteria:

  • Patients with acute sepsis, specific cause of fistula, strictured anorectum, and any degree of incontinence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042821

Locations
Egypt
Mansoura University Hospital
Mansoura, Egypt, 35111
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Wael Khafagy, MD Mansoura university hospital
  More Information

Additional Information:
Publications:
Responsible Party: dr waeil khafagy, Mansoura university hospital
ClinicalTrials.gov Identifier: NCT01042821     History of Changes
Other Study ID Numbers: anal fistula
Study First Received: January 5, 2010
Last Updated: January 5, 2010
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
anal fistula
advancement flap
incontinence

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 16, 2014