Clinical trial NCT01500889: Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF)
Official title: Comparative Study of Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-Y Anoplasty in Treatment of Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Anal Fissure
Keywords: Anal fissure
Advancement flap
Internal sphincterotomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line.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 The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure.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

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 1 year
Secondary outcomes:
measure: Secondary outcomes were operative time
timeFrame: 1 year
measure: length of hospital stay
timeFrame: one month
measure: anal incontenance
timeFrame: one year
measure: recurrence rate
timeFrame: one year
measure: postoperative anal manometery
timeFrame: one year
measure: complication
timeFrame: one month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: Alae magdy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Littlejohn DR, Newstead GL. Tailored lateral sphincterotomy for anal fissure. Dis Colon Rectum. 1997 Dec;40(12):1439-42. doi: 10.1007/BF02070709.
citation: Chambers W, Sajal R, Dixon A. V-Y advancement flap as first-line treatment for all chronic anal fissures. Int J Colorectal Dis. 2010 May;25(5):645-8. doi: 10.1007/s00384-010-0881-1. Epub 2010 Feb 23.
citation: Giordano P, Gravante G, Grondona P, Ruggiero B, Porrett T, Lunniss PJ. Simple cutaneous advancement flap anoplasty for resistant chronic anal fissure: a prospective study. World J Surg. 2009 May;33(5):1058-63. doi: 10.1007/s00268-009-9937-1.
citation: Hancke E, Rikas E, Suchan K, Volke K. Dermal flap coverage for chronic anal fissure: lower incidence of anal incontinence compared to lateral internal sphincterotomy after long-term follow-up. Dis Colon Rectum. 2010 Nov;53(11):1563-8. doi: 10.1007/DCR.0b013e3181f0869f.