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| Name | Class |
|---|---|
| Services Institute of Medical Sciences, Pakistan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-CLIS | Active Comparator | Closed Lateral Internal Sphincterotomy (CLIS) under spinal anesthesia |
|
| Group B-OLIS | Active Comparator | Open Lateral Internal Sphincterotomy (OLIS) under spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed Lateral Internal Sphincterotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with complete wound healing | Defined as evidence of scarring at the fissure site | 6 weeks |
| Anal incontinence | Wexner Continence Grading Scale | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain score through visual analog score | 24 hours |
| Return to work in days | 2 weeks | |
| Recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Awais Amjad Malik, MBBS, FCPS | Services Institute of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical Sciences | Lahore | Punjab Province | 54000 | Pakistan |
Informed consent did not explicitly include permission for sharing de-identified data with external researchers
Institutional ethical approval was obtained only for the primary analysis and publication, not for data sharing
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| Open Lateral Internal Sphincterotomy | Procedure | 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. |
|
Reappearance of ulcer or tear in previously healed scar |
| 1 year |