Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF)

Not Applicable

Completed

• Conditions: Chronic Anal Fissure

• Registration Number: NCT01500889
• Lead Sponsor: Mansoura University

Brief Summary

The investigators compared conventional lateral internal sphincterotomy (CLIS), V-Y anal flap, and combined tailored lateral internal sphincterotomy with V-Y anal flap (TLIS with V-YF) in a randomized prospective study in patients undergoing treatment for chronic anal fissure.

Detailed Description

Group I: Conventional Lateral internal sphincterotomy:

LIS was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line. Figures 5, 6, 7 and 8 illustrate the procedure.

GroupII: V-Y advancement flap:

The V-Y advancement flap was performed by making a V-shaped incision from the edges of the fissure extending about 4 cm from the anal verge and away from the midline. The V-shaped flap formed of skin and subcutaneous fat was mobilized sufficiently to allow advancement into the anal canal to cover the fissure defect. Care was taken to preserve enough pedicles to ensure adequate blood supply. The base of flap was sutured to the lower anal mucosa with interrupted 000 Vicryl Rapide. Figures 1, 2, 3 and 4 illustrate the procedure.

GroupIII: Tailored lateral internal sphincterotomy with V-Y advancement flap:

Tailored lateral sphincterotomy was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure. Then the V-Y advancement flap was performed All assessments were conducted by investigators who were blinded to the experimental condition. The primary outcome was complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure). Secondary outcomes were operative time, length of hospital stay, anal incontinence (determined by Pescatori scoring system (32), time of relieve of pain, postoperative anal manometery, complications (eccyhmosis, haematoma, infection, disruption of flap, flap necrosis), persistent symptoms, patients satisfaction ( assessed on a visual analogue scale VAS), recurrence rate and quality of life.

Quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) developed by Eypasch and coworkers

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-23
• Last Update Submitted: 2011-12-23
• Study First Posted: 2011-12-29
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• consecutive patients who treated for chronic anal fissure at colorectal surgery unite of Mansoura university hospital, Mansoura, Egypt.
• all patients were selected to have increased resting anal pressure above the upper limit of normal range.

Exclusion Criteria

• patients with acute fissure
• patients who had resting anal pressure within the normal range or less than the normal
• cicatricial deformation
• large sentinel pile
• inflammatory bowel disease hemorrhoids
• fistula in ano and anal abscesses
• those who had undergone previous surgical procedure in the anal canal
• age above 80 years
• vascular disease
• scleroderma
• malnutrition
• coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure).	1 year	complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure).

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were operative time	1 year	Secondary outcomes were operative time, length of hospital stay, anal incontinence (determined by Pescatori scoring system (32), time of relieve of pain, postoperative anal manometery, complications (eccyhmosis, haematoma, infection, disruption of flap, flap necrosis), persistent symptoms, patients satisfaction ( assessed on a visual analogue scale VAS), recurrence rate and quality of life.
length of hospital stay	one month	early postoperative hospital stay
anal incontenance	one year	using pescatori scoring
recurrence rate	one year	recurrence rate
postoperative anal manometery	one year	resting anal pressure
complication	one month	necrosis, infection

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt