We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883571
First Posted: April 17, 2009
Last Update Posted: December 29, 2009
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.
Information provided by:
Mansoura University
  Purpose
This prospective randomized study included 60 consecutive patients suffering from anal stenosis in the period from April 2002 to December 2008. They admitted to colorectal surgery unit, Mansoura university hospital, Egypt. According to the classification proposed by Milson and Mazier(5), all patients had moderate to severe anal stenosis. There were 43 males and 17 female with a mean age 34 + 5.2 years ranging from 18 up to 63 years.

Condition Intervention
Anal Stenosis Procedure: house advancement flap group Procedure: Rhomboid flap GROUP Procedure: Y-V anoplasty GROUP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty in Treatment of Anal Stenosis: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • postoperative anal caliber [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life [ Time Frame: 1 year ]

Enrollment: 60
Study Start Date: April 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: house advancement flap
house advancement flap
Procedure: house advancement flap group
A house flap of healthy tissue was incised to the depth of ischiorectal fat. The flap consisted of skin and subcutaneous tissue. The flap was sufficiently mobilized without undermining its fatty base containing perforating blood vessels. The flap should be loose and easily advanced into the anal canal. When the ''base'' of this house-shaped flap was advanced into the anal canal defect, it was fixed to the top of the excised area with 3/0 Vicryl sutures.
Other Name: group 1
Active Comparator: Rhomboid flap
rhomboid flapa was incised in the ischiorectal fossa. Without undermining of its fatty base, the flap was then mobilized into the anal canal so that the tip could be sutured to the top of the strictured area using Vicryl 3/0 sutures
Procedure: Rhomboid flap GROUP
A rhomboid flap was incised in ischeorectal fossa and was mobilized without undermining of its fatty base into the anal canal so that the tip of rhomboid flap is sutured to the top of stricured area using vicryl 3/0.
Other Name: Group 11
Active Comparator: Y-V anoplasty
Y-V anoplasty
Procedure: Y-V anoplasty GROUP
Y-V anoplastyis performed by making a v shaped incision in the perianal skin posteriorly starting from the lower end of the wound resultant from excision of scared area. A V-shaped flap is then dissected with preservation fatty base .The V flap is then advanced into the anal canal so that its tip is sutured to the top of structured area using vicryel 3/0.
Other Name: group 111

  Show Detailed Description

  Eligibility

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:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ALL PATIENTS with anal stenosis

Exclusion Criteria:

  • Pregnant female
  • Malignant stenosis
  • Associated anal pathology
  • Anal stenosis with a anal diameter more than 20 mm
  Contacts and Locations
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): NCT00883571


Locations
Egypt
Mansoura University
Mansoura, Egypt, 35111
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: mohamed yousef Mansoura University
  More Information

Additional Information:
Publications:
Responsible Party: Mohmed Youssef, MANSOURA UNIVERSITY
ClinicalTrials.gov Identifier: NCT00883571     History of Changes
Other Study ID Numbers: anal stenosis
First Submitted: April 16, 2009
First Posted: April 17, 2009
Last Update Posted: December 29, 2009
Last Verified: April 2009

Keywords provided by Mansoura University:
anal stenosis
flaps
anoplasty

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical