Chronic Anal Fissure Clinical Trial
— CAFOfficial 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
Verified date | December 2011 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
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. — View 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. — View Citation
Hancke E, Rikas E, Suchan K, Völke 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.0b0 — View Citation
Littlejohn DR, Newstead GL. Tailored lateral sphincterotomy for anal fissure. Dis Colon Rectum. 1997 Dec;40(12):1439-42. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Secondary outcomes were operative time | 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. | 1 year | Yes |
Secondary | length of hospital stay | early postoperative hospital stay | one month | Yes |
Secondary | anal incontenance | using pescatori scoring | one year | Yes |
Secondary | recurrence rate | recurrence rate | one year | Yes |
Secondary | postoperative anal manometery | resting anal pressure | one year | Yes |
Secondary | complication | necrosis, infection | one month | Yes |
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