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

Trial Information
Status: Unknown status
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
Summary

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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Maximum Age:
45
Healthy Volunteers:
No

• Patients with CAFs that had failed conservative therapy and required surgical treatment

When is this trial taking place?
Start Date: May 1, 2013
Completion Date: August 1, 2020
How many participants will be in this trial?
Target number of participants: 200
What treatment is being studied in this trial?
Experimental: Sungurtekin Technique
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
Active Comparator: Closed Lateral Internal Sphincterotomy
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.

This content was sourced from clinicaltrials.gov

Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
Status:Not yet recruiting
Start Date:April 1, 2021
Study Type:Device
Phase: Not Applicable
A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
Who is this study for:Patients with chronic anal fissure
Status:Recruiting
Start Date:September 1, 2019
Study Drug:IncobotulinumtoxinA
Study Type:Procedure, Drug
Phase: Phase 4