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