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Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

NCT04428697 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-06-11

No results posted yet for this study

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.

Conditions

  • Anal Fissure

Interventions

PROCEDURE

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, 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 .

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Principal Investigators

  • Ugur Sungurtekin, MD · Pamukkale University Department Of Surgery,Colorectal Surgery Division

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-01
Primary Completion
2020-05-01
Completion
2020-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428697 on ClinicalTrials.gov