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Comparative Study Between Housedoor Flap, Rhomboid Flap, and V-Y Anoplasty in Treatment of Anal Stenosis
This study has been completed.
First Received: April 16, 2009   No Changes Posted
Sponsored by: Mansoura University
Information provided by: Mansoura University
ClinicalTrials.gov Identifier: NCT00883571
  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: housedoor flap group
Procedure: a rhomboid flap GROUP
Procedure: V-Y anoplasty GROUP

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Comparative Study Between Housedoor Flap, Rhomboid Flap, and V-Y Anoplasty in Treatment of Anal Stenosis

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • patients satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence [ Time Frame: 2 years ] [ 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
1: Active Comparator
housedoor flap
Procedure: housedoor 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.
2: Active Comparator
rhomboid flap
Procedure: a 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.
3: Active Comparator
V-Y anoplasty
Procedure: V-Y anoplasty GROUP
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 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.

Detailed Description:

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 housedoor 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 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. Patients were discharged 48 hours after the procedure. A high-fiber diet combined with bulk laxatives with oral antibiotic coverage was recommended after discharge. After each bowel movement, cleansing of the operative site with a sitz bath or shower was prescribed.

Patients were discharged 48 hours after the procedure. A high-fiber diet combined with bulk laxatives with oral antibiotic coverage was recommended after discharge. After each bowel movement, cleansing of the operative site with a sitz bath or shower was prescribed.

The parameters investigated were time of relief of painful defecation, the straining severity, sensation of incomplete evacuation and need for laxative or enema. postoperative anal caliber, healing rate, recurrence, quality of life (QOL) was assessed with Gastrointestinal quality of life index (GIQLI) which is a relatively new and validated tool for measuring the QOL in patients with gastrointestinal diseases. The GIQLI developed by Eypasch and coworkers (6). The questionnaire comprises 36 multidimensional items covering symptoms and physical, emotional, and social dysfunction related to gastrointestinal diseases or their treatments. Each item is scored from 0 to 4 points. The GIQLI score is calculated by simple addition of all item scores so that an overall score of 0 would constitute the worst, while a score of 144 (36 X 4) represents the best possible result. It is also possible to evaluate the disease-specific, social, psychologic, and physical items as separate subgroups. The patients were asked to complete the GIQLI questionnaire at admission to the hospital and one year after surgery under the supervision of the same independent authors.

  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
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

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

Keywords provided by Mansoura University:
anal stenosis
flaps
anoplasty

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Constriction, Pathologic

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

ClinicalTrials.gov processed this record on May 06, 2009