Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF)
CAF
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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedDecember 29, 2011
December 1, 2011
1.9 years
December 15, 2011
December 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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
Secondary Outcomes (6)
Secondary outcomes were operative time
1 year
length of hospital stay
one month
anal incontenance
one year
recurrence rate
one year
postoperative anal manometery
one year
- +1 more secondary outcomes
Study Arms (3)
CLI sphincterotomy
ACTIVE COMPARATORConventional 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
ACTIVE COMPARATORThe 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.
TLIS with VY anoplasty
ACTIVE COMPARATORTailored 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, Egypt
Related Publications (4)
Littlejohn DR, Newstead GL. Tailored lateral sphincterotomy for anal fissure. Dis Colon Rectum. 1997 Dec;40(12):1439-42. doi: 10.1007/BF02070709.
PMID: 9407982RESULTChambers 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.
PMID: 20177691RESULTGiordano 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.
PMID: 19225835RESULTHancke 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.
PMID: 20940607RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alae magdy, MD
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculity of medicine, mansoura university
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 29, 2011
Study Start
January 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 29, 2011
Record last verified: 2011-12