Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure (SPHINX)

May 12, 2026 updated by: Emre Gülçek, Çanakkale Onsekiz Mart University

A Prospective Randomized Controlled Trial Comparing Spasm-Controlled, Fissure Apex-Limited, and Dentate Line-Limited Lateral Internal Sphincterotomy Techniques in Chronic Anal Fissure

This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic anal fissure (CAF) is a longitudinal tear in the anoderm persisting for more than 8 weeks. Lateral internal sphincterotomy (LIS) is the gold-standard surgical treatment for CAF refractory to medical management, achieving healing rates of 90-98%. However, postoperative fecal incontinence remains its most significant complication, with rates ranging from 1-15% for permanent incontinence.

To reduce incontinence risk, various techniques limiting the extent of sphincterotomy have been proposed. Mentes et al. (2005) demonstrated that LIS up to the dentate line provided faster healing but caused significant continence disturbance, while LIS limited to the fissure apex was associated with lower incontinence but a higher treatment failure rate. Mentes et al. (2008) subsequently showed that spasm-controlled LIS using anal calibrators achieved faster pain relief with lower early incontinence rates compared to fissure apex sphincterotomy. However, no randomized trial has compared all three techniques simultaneously.

This single-center, prospective, three-arm RCT will enroll 150 adult patients with CAF refractory to at least 6 weeks of medical treatment. Patients will be randomized (1:1:1) to one of three groups: Group 1 (Spasm-Controlled LIS): serial small sphincterotomies under local anesthesia plus sedation until anal caliber reaches 30 mm using an anal calibrator. Group 2 (LIS up to Fissure Apex): open sphincterotomy extended to the proximal end of the fissure under spinal or general anesthesia. Group 3 (LIS up to Dentate Line): open sphincterotomy extended to the dentate line under spinal or general anesthesia.

All procedures will use the open technique with patients in lithotomy position. Randomization will be performed using computer-generated block randomization (block size 6), stratified by sex and fissure location. Outcome assessors will be blinded to group allocation.

Patients will be evaluated preoperatively and at postoperative day 1, week 1, week 2, month 1, month 2, month 6, and month 12. The Wexner (Cleveland Clinic) Incontinence Score will be used to assess continence at each visit. Fissure healing will be defined as complete epithelialization with no symptoms. Statistical analysis will follow the intention-to-treat principle, with Bonferroni correction applied for multiple comparisons.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • Turkey (Türkiye)
    • Çanakkale
      • Çanakkale, Çanakkale, Turkey (Türkiye), 00017
        • Recruiting
        • Çanakkale Onsekiz Mart University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of chronic anal fissure (duration ≥8 weeks)
  • Failure to heal after at least 6 weeks of appropriate medical treatment (topical agents, fiber supplementation, sitz baths)
  • Complete preoperative fecal continence (Wexner Incontinence Score = 0)
  • Primary anal fissure (posterior or anterior midline location)
  • Written informed consent

Exclusion Criteria:

  • Any degree of preoperative fecal incontinence
  • Secondary anal fissure (associated with Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions)
  • Previous anal sphincter surgery
  • History of obstetric sphincter injury
  • Active anorectal infection (abscess or fistula)
  • Pregnancy or breastfeeding
  • Uncorrectable coagulopathy or current anticoagulant use
  • Inability to cooperate with study procedures or attend follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Spasm-Controlled LIS
Serial small open sphincterotomies performed under local anesthesia plus IV sedation. Anal caliber is measured with an anal calibrator before and after each increment until a caliber of 30 mm is achieved.
Procedure: Spasm-Controlled Lateral Internal Sphincterotomy
Serial small open sphincterotomies under local anesthesia plus IV sedation using an anal calibrator until anal caliber of 30 mm is achieved.
Other Names:
  • Calibrated LIS
Active Comparator: LIS up to Fissure Apex
Open lateral internal sphincterotomy extended to the proximal end of the fissure (fissure apex) under spinal or general anesthesia. The length of sphincterotomy equals the length of the fissure.
Procedure: Lateral Internal Sphincterotomy up to Fissure Apex
Open LIS extended to the proximal end of the fissure under spinal or general anesthesia.
Other Names:
  • Tailored LIS
Active Comparator: LIS up to Dentate Line
Open lateral internal sphincterotomy extended to the level of the dentate line under spinal or general anesthesia. This is the traditional (classical) LIS technique.
Procedure: Lateral Internal Sphincterotomy up to Dentate Line
Open LIS extended to the level of the dentate line under spinal or general anesthesia.
Other Names:
  • Traditional LIS / Classical LIS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fissure Healing Rate
Time Frame: 12 months
Complete epithelialization of the anal fissure with no symptoms at 12 months postoperatively, assessed by clinical examination.
12 months
Fecal Incontinence Incidence
Time Frame: 12 months
Incidence of de novo fecal incontinence assessed using the Wexner (Cleveland Clinic) Incontinence Score. A score increase of ≥1 point from preoperative baseline is defined as de novo incontinence.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: Day 1, Week 1, Week 2, Month 1, Month 2, Month 6, Month 12
Pain assessed using the Visual Analog Scale (VAS, 0-10) at each follow-up visit.
Day 1, Week 1, Week 2, Month 1, Month 2, Month 6, Month 12
Recurrence Rate
Time Frame: Month 6 and Month 12
Proportion of patients with recurrence of anal fissure after an initial healing period.
Month 6 and Month 12
Patient Satisfaction
Time Frame: Month 2, Month 6, Month 12
Patient satisfaction assessed on a numeric scale (0-10) at follow-up visits.
Month 2, Month 6, Month 12
Postoperative Complications
Time Frame: 12 months
Rate of surgical complications including bleeding, hematoma, infection, abscess, and fistula.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çanakkale Onsekiz Mart University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAF-LIS-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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