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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alaa Magdy, Mansoura University
ClinicalTrials.gov Identifier:
NCT01500889
First received: December 15, 2011
Last updated: December 23, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Chronic Anal Fissure
Procedure: Group I: Conventional Lateral internal sphincterotomy:
Procedure: GroupII: V-Y advancement flap
Procedure: GroupIII: Tailored LIS with V-Y advancement flap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Secondary outcomes were operative time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    early postoperative hospital stay

  • anal incontenance [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    using pescatori scoring

  • recurrence rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    recurrence rate

  • postoperative anal manometery [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    resting anal pressure

  • complication [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    necrosis, infection


Enrollment: 150
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CLI sphincterotomy
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.
Procedure: 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.
Other Name: Group 1
Active Comparator: 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.
Procedure: GroupII: V-Y advancement flap

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.

Other Name: Group 11
Active Comparator: TLIS with VY anoplasty
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.
Procedure: GroupIII: Tailored LIS 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.
Other Name: Group III

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

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01500889

Locations
Egypt
Mansoura University
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Alae magdy, MD Mansoura University
  More Information

Publications:
Responsible Party: Alaa Magdy, Faculity of medicine, mansoura university, Mansoura University
ClinicalTrials.gov Identifier: NCT01500889     History of Changes
Other Study ID Numbers: anal fissure
Study First Received: December 15, 2011
Last Updated: December 23, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Anal fissure
Advancement flap
Internal sphincterotomy

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014