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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Fiss

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 Summary:

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 The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line.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 The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure.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

Current Primary Outcome: 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). [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Secondary outcomes were operative time [ Time Frame: 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 [ Time Frame: one month ]
    early postoperative hospital stay
  • anal incontenance [ Time Frame: one year ]
    using pescatori scoring
  • recurrence rate [ Time Frame: one year ]
    recurrence rate
  • postoperative anal manometery [ Time Frame: one year ]
    resting anal pressure
  • complication [ Time Frame: one month ]
    necrosis, infection


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: December 15, 2011
Date Started: January 2009
Date Completion:
Last Updated: December 23, 2011
Last Verified: December 2011