Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF)
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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 |
- 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 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 |
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 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 May 23, 2013