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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty in Treatment of Anal Stenosis: A Prospective Randomized Study

Brief Summary: 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.

Detailed Summary:

Informed consent was obtained from all patients to be included in the study, after explanations the nature of the disease and possible treatment. This study was approved by local ethical committee.

The patients were then randomized into three groups. The randomization was achieved through computer-generated schedule and its results were sealed into 60 envelopes. The responsible surgeon opened randomly an envelop and, accordingly to the protocol.

Group 1: consists of 20 (14 males and 6 females) patients underwent house door flap.

Group II: consists of 20 patients (16 males and 4 females) underwent romboid flap.

Group III: consists of 20 patients underwent V-Y anoplasty (13 males and 7 females).

In group I: 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.

In group II: a rhomboid flap was incised in ischiorectal 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 strictured area using vicryl 3/0.

In group III: V-Y anoplasty is 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
Sponsor: Mansoura University

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

Original Primary Outcome: patients satisfaction [ Time Frame: 2 years ]

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

Original Secondary Outcome: recurrence [ Time Frame: 2 years ]

Information By: Mansoura University

Date Received: April 16, 2009
Date Started: April 2002
Date Completion:
Last Updated: December 28, 2009
Last Verified: April 2009