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This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.
Chronic anal fissure (CAF) is a longitudinal tear in the anoderm persisting for more than 8 weeks. Lateral internal sphincterotomy (LIS) is the gold-standard surgical treatment for CAF refractory to medical management, achieving healing rates of 90-98%. However, postoperative fecal incontinence remains its most significant complication, with rates ranging from 1-15% for permanent incontinence.
To reduce incontinence risk, various techniques limiting the extent of sphincterotomy have been proposed. Mentes et al. (2005) demonstrated that LIS up to the dentate line provided faster healing but caused significant continence disturbance, while LIS limited to the fissure apex was associated with lower incontinence but a higher treatment failure rate. Mentes et al. (2008) subsequently showed that spasm-controlled LIS using anal calibrators achieved faster pain relief with lower early incontinence rates compared to fissure apex sphincterotomy. However, no randomized trial has compared all three techniques simultaneously.
This single-center, prospective, three-arm RCT will enroll 150 adult patients with CAF refractory to at least 6 weeks of medical treatment. Patients will be randomized (1:1:1) to one of three groups: Group 1 (Spasm-Controlled LIS): serial small sphincterotomies under local anesthesia plus sedation until anal caliber reaches 30 mm using an anal calibrator. Group 2 (LIS up to Fissure Apex): open sphincterotomy extended to the proximal end of the fissure under spinal or general anesthesia. Group 3 (LIS up to Dentate Line): open sphincterotomy extended to the dentate line under spinal or general anesthesia.
All procedures will use the open technique with patients in lithotomy position. Randomization will be performed using computer-generated block randomization (block size 6), stratified by sex and fissure location. Outcome assessors will be blinded to group allocation.
Patients will be evaluated preoperatively and at postoperative day 1, week 1, week 2, month 1, month 2, month 6, and month 12. The Wexner (Cleveland Clinic) Incontinence Score will be used to assess continence at each visit. Fissure healing will be defined as complete epithelialization with no symptoms. Statistical analysis will follow the intention-to-treat principle, with Bonferroni correction applied for multiple comparisons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spasm-Controlled LIS | Active Comparator | Serial small open sphincterotomies performed under local anesthesia plus IV sedation. Anal caliber is measured with an anal calibrator before and after each increment until a caliber of 30 mm is achieved. |
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| LIS up to Fissure Apex | Active Comparator | Open lateral internal sphincterotomy extended to the proximal end of the fissure (fissure apex) under spinal or general anesthesia. The length of sphincterotomy equals the length of the fissure. |
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| LIS up to Dentate Line | Active Comparator | Open lateral internal sphincterotomy extended to the level of the dentate line under spinal or general anesthesia. This is the traditional (classical) LIS technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spasm-Controlled Lateral Internal Sphincterotomy | Procedure | Serial small open sphincterotomies under local anesthesia plus IV sedation using an anal calibrator until anal caliber of 30 mm is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Fissure Healing Rate | Complete epithelialization of the anal fissure with no symptoms at 12 months postoperatively, assessed by clinical examination. | 12 months |
| Fecal Incontinence Incidence | Incidence of de novo fecal incontinence assessed using the Wexner (Cleveland Clinic) Incontinence Score. A score increase of ≥1 point from preoperative baseline is defined as de novo incontinence. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | Pain assessed using the Visual Analog Scale (VAS, 0-10) at each follow-up visit. | Day 1, Week 1, Week 2, Month 1, Month 2, Month 6, Month 12 |
| Recurrence Rate | Proportion of patients with recurrence of anal fissure after an initial healing period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emre Gülçek, MD, Assistant Professor | Contact | +905544810964 | emre.gulcek@comu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canakkale Onsekiz Mart University | Recruiting | Çanakkale | Çanakkale | 00017 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17665247 | Result | Elsebae MM. A study of fecal incontinence in patients with chronic anal fissure: prospective, randomized, controlled trial of the extent of internal anal sphincter division during lateral sphincterotomy. World J Surg. 2007 Oct;31(10):2052-7. doi: 10.1007/s00268-007-9177-1. | |
| 18085337 | Result | Mentes BB, Guner MK, Leventoglu S, Akyurek N. Fine-tuning of the extent of lateral internal sphincterotomy: spasm-controlled vs. up to the fissure apex. Dis Colon Rectum. 2008 Jan;51(1):128-33. doi: 10.1007/s10350-007-9121-3. Epub 2007 Dec 18. |
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Three-arm parallel group randomized controlled trial comparing three lateral internal sphincterotomy techniques (spasm-controlled, up to fissure apex, and up to dentate line) in a 1:1:1 allocation ratio.
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The surgeon performing the procedure is aware of the group allocation as blinding is not feasible for surgical technique trials. Patients are aware of their anesthesia type but are not informed of their specific group assignment until after the study. Data analysts will be blinded to group allocation during statistical analysis.
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| Lateral Internal Sphincterotomy up to Fissure Apex | Procedure | Open LIS extended to the proximal end of the fissure under spinal or general anesthesia. |
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| Lateral Internal Sphincterotomy up to Dentate Line | Procedure | Open LIS extended to the level of the dentate line under spinal or general anesthesia. |
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| Month 6 and Month 12 |
| Patient Satisfaction | Patient satisfaction assessed on a numeric scale (0-10) at follow-up visits. | Month 2, Month 6, Month 12 |
| Postoperative Complications | Rate of surgical complications including bleeding, hematoma, infection, abscess, and fistula. | 12 months |
| 15711861 | Result | Mentes BB, Ege B, Leventoglu S, Oguz M, Karadag A. Extent of lateral internal sphincterotomy: up to the dentate line or up to the fissure apex? Dis Colon Rectum. 2005 Feb;48(2):365-70. doi: 10.1007/s10350-004-0812-8. |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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