Clinical trial NCT04428697: Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique
Official title: Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano: A Prospective, Randomized, Controlled Trial of a New Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fissure
Keywords: Fissure-in-ano
Sphincterotomy
İncontinence
Surgical technique
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

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

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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

Primary outcomes:
measure: Recurrence
timeFrame: 1-24 month
measure: Postoperatif pain
timeFrame: Postopetaive 3th day
measure: Incontinence Rate
timeFrame: 12th month
measure: Complications
timeFrame: 1-24 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University Department Of Surgery,Colorectal Surgery Division
name: Ugur Sungurtekin, MD
role: STUDY_DIRECTOR
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