ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Anal Fistulas Advancement Flap (flap)

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: NCT01042821
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : January 6, 2010
Sponsor:
Information provided by:
Mansoura University

Brief Summary:
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 or disease Intervention/treatment Phase
Anal Fistula Procedure: partial rectal wall advancement flap Procedure: mucosal advancement flap Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Anal Fistulas by Partial Rectal Wall Advancement Flap or Mucosal Advancement Flap: a Prospective Randomized Study
Study Start Date : May 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. RECURRENCE OF THE FISTULA [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. healing, complication, patient satisfaction [ Time Frame: 12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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): NCT01042821


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

Additional Information:
Publications of Results:
Responsible Party: dr waeil khafagy, Mansoura university hospital
ClinicalTrials.gov Identifier: NCT01042821     History of Changes
Other Study ID Numbers: anal fistula
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: January 6, 2010
Last Verified: May 2005

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