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

Anal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883571
• Other study ID #: anal stenosis
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: December 28, 2009
• Start date: April 2002
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Stenosis
• Constriction, Pathologic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Alver O, Ersoy YE, Aydemir I, Erguney S, Teksoz S, Apaydin B, Ertem M. Use of "house" advancement flap in anorectal diseases. World J Surg. 2008 Oct;32(10):2281-6. doi: 10.1007/s00268-008-9699-1. — View Citation

Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmülling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. — View Citation

Habr-Gama A, Sobrado CW, de Araújo SE, Nahas SC, Birbojm I, Nahas CS, Kiss DR. Surgical treatment of anal stenosis: assessment of 77 anoplasties. Clinics (Sao Paulo). 2005 Feb;60(1):17-20. Epub 2005 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative anal caliber		1 year	Yes
Secondary	clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life		1 year	Yes

External Links

•   mansoura university hospital