Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

Study Overview
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Brief Summary
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BACKGROUND: Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure. However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence. OBJECTIVE: To compare a new ultra-modified internal sphincterotomy technique to the closed lateral sphincterotomy for treating chronic anal fissures, based on internal anal sphincter function and postoperative complications. DESIGN: Prospective, randomized, controlled trial (block randomization method) SETTING: Pamukkale University hospital in Denizli-Turkey PARTICIPANTS: 200 patients with chronic anal fissures INTERVENTION: Patients were randomly assigned to receive either Sungurtekin technique (n = 100; ultra-modified group), or the closed lateral internal sphincterotomy (n = 100; closed-lateral group). Follow-up was 2 years. MAIN OUTCOME MEASURES: The primary outcome was chronic anal fissure healing. The secondary outcomes were complications, visual analog scale pain scores, sphincter pressures, and incontinence scores.

Detailed Description
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Although the lateral internal sphincterotomy is the treatment of choice for CAF, it has several drawbacks. First, the lower portion of the internal sphincter is nested in the lowermost part of the anus. Thus, an incision from the fissure base up to the dentate line removes support to the inner sphincter structure on the incision site. In our opinion; this is the main cause of different levels of incontinence developing in the postoperative period. Second, the internal sphincter muscle is shorter in women than in men. Therefore, women are at higher risk of postoperative anal incontinence than men. Third, because the lateral internal sphincterotomy is not standardized, the length of the internal sphincter incision varies, depending on the surgeon's discretion and competency. Fourth, an incision that is too short increases in the risk of recurrence. The investigators believe that this observation could be explained by the fact that the length of the incision required for a lateral internal sphincterotomy procedure has not been standardized

Official Title
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Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano: A Prospective, Randomized, Controlled Trial of a New Technique

Conditions
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Anal Fissure

Intervention / Treatment
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* Procedure: Sungurtekin Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CAFs that had failed conservative therapy and required surgical treatment - Exclusion Criteria: Patients who have a low resting anal pressure in manometric study (lower than 40 mmHg) Recurrent anal fissure Fissure location other than the posterior anal canal Fissure due to inflammatory bowel or infectious disease Acute anal fissure, Fissure due to chronic diarrhea or anal stenosis Anorectal malignancy Patients undergone pelvic radiotherapy Pregnancy Patients with history of diabetes, neurological disease and spinal cord lesions Previous episiotomy history Painless fissures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sungurtekin Technique<br>Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm. After identifying both the internal and external sphincters completely, under direct vision, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. This section was preserved during the operation in a standard fashion for all patients . Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter bundle was elevated with a right angle clamp, then cut with cautery . The operation was completed with meticulous hemostasis and additional suturing (3/0 absorbable suture) of the proximally dissected mucosal flap underlying the muscularis layer | Procedure: Sungurtekin Technique<br>* Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter cut with cautery .<br>|
| Active Comparator: Closed Lateral Internal Sphincterotomy<br>The sphincterotomy was performed through a new incision, guided by the surgeon's finger, as described by Boulos et al Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? The British journal of surgery 1984;71:360-2. | Procedure: Sungurtekin Technique<br>* Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter cut with cautery .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | It has been reported in the literature that healing was completed in 6-8 weeks in patients undergoing this operation. During this period, it was accepted that the fissure was no longer detected as a visual examination finding and that patient complaints disappeared. | 1-24 month | 
| Postoperatif pain | The patients asked to record postoperative pain scores with VAS(Visual Analog Scale)Graded from 0.0 to 10.0. and measured postoperative day 3 .As low as possible this pain score value indicates that the patient is exposed to less pain. | Postopetaive 3th day | 
| Incontinence Rate | Pre and postoperative fecal continence were scored using the Cleveland Clinic Florida Fecal Incontinence (CCF-FI) scores. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 12 months. The scores from 0 indicate perfect continence to a maximum of 20 indicates complete incontinence The CCF FI scale combines loss of flatus, liquid and solid stool, use of a pad and the impact on the quality of life a assess the severity of fecal incontinence. | 12th month | 
| Complications | Urinary retansion,ecchymosis,itching,bleeding,abscess,fistula has been accepted as postoperative complications | 1-24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fissure-in-ano, Sphincterotomy, İncontinence, Surgical technique