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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00883571
First received: April 16, 2009
Last updated: December 28, 2009
Last verified: April 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • postoperative anal caliber [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00883571

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

Publications:
Responsible Party: Mohmed Youssef, MANSOURA UNIVERSITY
ClinicalTrials.gov Identifier: NCT00883571     History of Changes
Other Study ID Numbers: anal stenosis
Study First Received: April 16, 2009
Last Updated: December 28, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
anal stenosis
flaps
anoplasty

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

ClinicalTrials.gov processed this record on October 19, 2014