Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

Pamukkale University

Status: Unknown

Conditions: Anal Fissure

Treatments: Procedure: Sungurtekin Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04428697

Sungurtekin 01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Sungurtekin Technique

Experimental group

Description:

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

Treatment:

Procedure: Sungurtekin Technique

Closed Lateral Internal Sphincterotomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Sungurtekin Technique