Chronic Anal Fissure
Conditions
Keywords
Chronic Anal Fissure, Lateral Internal Sphincterotomy, Closed Technique, Open Technique, Wound Healing
Brief summary
This randomized controlled trial will compare closed versus open lateral internal sphincterotomy (LIS) under spinal anesthesia in patients with chronic anal fissure. The study will evaluate wound healing rates, postoperative pain, return to work, anal incontinence, and recurrence. A total of 160 patients will be randomized equally to either closed LIS or open LIS. The primary outcome will be complete wound healing at 6 weeks. Secondary outcomes include pain at 24 hours measured by Visual Analog Scale (VAS), return to work (days), anal incontinence at 6 weeks and 1 year, and recurrence at 1 year. Multivariate analysis will identify independent predictors of non-healing.
Interventions
A bivalve anal retractor will be inserted to visualize the intersphincteric groove. A number 11 scalpel blade will be introduced into the intersphincteric groove in the left lateral position, advanced to the level of the dentate line, and then rotated medially to divide the internal anal sphincter. A dry gauze wick soaked with xylocaine gel will be placed in the anal canal for hemostasis and removed on the evening of the operation day.
PROCEDUREOpen Lateral Internal Sphincterotomy
A 1-2 cm curvilinear incision will be made in the intersphincteric groove in the left lateral position. The intersphincteric plane will be dissected to expose the internal anal sphincter, which will then be divided under direct vision up to the level of the dentate line. The wound will be left open to heal by secondary intention.
Sponsors
Services Hospital, Lahore
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic anal fissure (symptoms \> 6 weeks) * Failure of conservative medical management (dietary fiber, stool softeners, topical lignocaine, and at least 4 weeks of topical glyceryl trinitrate 0.2%) * Willing to provide informed consent
Exclusion criteria
* Multiple fissures * Concomitant anorectal pathology (anal fistula, abscess, significant hemorrhoids, rectal cancer) * Inflammatory bowel disease * Previous anorectal surgery * History of anoreceptive intercourse * Psychiatric disease or inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients with complete wound healing | 6 weeks | Defined as evidence of scarring at the fissure site |
| Anal incontinence | 6 weeks | Wexner Continence Grading Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 24 hours | Pain score through visual analog score |
| Return to work in days | 2 weeks | — |
| Recurrence | 1 year | Reappearance of ulcer or tear in previously healed scar |
Countries
Pakistan
Contacts
STUDY_DIRECTORAwais Amjad Malik, MBBS, FCPS
Services Institute of Medical Sciences
Outcome results
None listed