Clinical trial NCT00883571: Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty
Official title: Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty in Treatment of Anal Stenosis: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Stenosis
Keywords: anal stenosis
flaps
anoplasty
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: postoperative anal caliber
timeFrame: 1 year
Secondary outcomes:
measure: clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: mohamed yousef
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habr-Gama A, Sobrado CW, de Araujo 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. doi: 10.1590/s1807-59322005000100005. Epub 2005 Mar 1.
citation: 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.
citation: Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling 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. doi: 10.1002/bjs.1800820229.