Chronic Anal FissureLIS-CLOSED TriNCT07496216
Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure
A study testing Closed Lateral Internal Sphincterotomy and Open Lateral Internal Sphincterotomy in people with Chronic Anal Fissure, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
This randomized controlled trial will compare closed versus open lateral internal sphincterotomy (LIS) under spinal anesthesia in patients with chronic anal fissure. The study will evaluate wound healing rates, postoperative pain, return to work, anal incontinence, and recurrence. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- Closed Lateral Internal Sphincterotomy and Open Lateral Internal Sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2019to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic anal fissure (symptoms > 6 weeks)
- Failure of conservative medical management (dietary fiber, stool softeners, topical lignocaine, and at least 4 weeks of topical glyceryl trinitrate 0.2%)
- Willing to provide informed consent
Who cannot join
- Multiple fissures
- Concomitant anorectal pathology (anal fistula, abscess, significant hemorrhoids, rectal cancer)
- Inflammatory bowel disease
- Previous anorectal surgery
- History of anoreceptive intercourse
- Psychiatric disease or inability to consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 54000
About this study
Official title: Outcomes of Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure: A Randomized Controlled Trial
This randomized controlled trial will compare closed versus open lateral internal sphincterotomy (LIS) under spinal anesthesia in patients with chronic anal fissure. The study will evaluate wound healing rates, postoperative pain, return to work, anal incontinence, and recurrence. A total of 160 patients will be randomized equally to either closed LIS or open LIS. The primary outcome will be complete wound healing at 6 weeks. Secondary outcomes include pain at 24 hours measured by Visual Analog Scale (VAS), return to work (days), anal incontinence at 6 weeks and 1 year, and recurrence at 1 year. Multivariate analysis will identify independent predictors of non-healing.
- Conditions
- Chronic Anal Fissure
- Being tested
- Closed Lateral Internal Sphincterotomy, Open Lateral Internal Sphincterotomy
- Keywords
- Chronic Anal Fissure, Lateral Internal Sphincterotomy, Closed Technique, Open Technique, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Lateral Internal SphincterotomyProcedure or surgery
A bivalve anal retractor will be inserted to visualize the intersphincteric groove. A number 11 scalpel blade will be introduced into the intersphincteric groove in the left lateral position, advanced to the level of the dentate line, and then rotated medially to divide the internal anal sphincter. A dry gauze wick soaked with xylocaine gel will be placed in the anal canal for hemostasis and removed on the evening of the operation day.
Open Lateral Internal SphincterotomyProcedure or surgery
A 1-2 cm curvilinear incision will be made in the intersphincteric groove in the left lateral position. The intersphincteric plane will be dissected to expose the internal anal sphincter, which will then be divided under direct vision up to the level of the dentate line. The wound will be left open to heal by secondary intention.
| Study group | Role | What they receive |
|---|---|---|
| Group A-CLIS | Active comparator | Closed Lateral Internal Sphincterotomy (CLIS) under spinal anesthesia Receives: Procedure: Closed Lateral Internal Sphincterotomy |
| Group B-OLIS | Active comparator | Open Lateral Internal Sphincterotomy (OLIS) under spinal anesthesia Receives: Procedure: Open Lateral Internal Sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with complete wound healing
Defined as evidence of scarring at the fissure site
Measured: 6 weeks
Anal incontinence
Wexner Continence Grading Scale
Measured: 6 weeks
Secondary outcomes (3)
Pain score
Pain score through visual analog score
Measured: 24 hours
Return to work in days
Measured: 2 weeks
Recurrence
Reappearance of ulcer or tear in previously healed scar
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Feb 2019
- Primary completion31 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Awais Amjad Malik, MBBS, FCPS, Study director, Services Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496216
- Sponsor's protocol ID
- RCT30SIMS
- Acronym
- LIS-CLOSED Tri
- Status last verified
- Feb 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Informed consent did not explicitly include permission for sharing de-identified data with external researchers Institutional ethical approval was obtained only for the primary analysis and publication, not for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07496216
- Acronym / sponsor ID
- LIS-CLOSED Tri / RCT30SIMS
- Conditions
- Chronic Anal Fissure
- Keywords
- Chronic Anal Fissure, Lateral Internal Sphincterotomy, Closed Technique, Open Technique, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will compare closed versus open lateral internal sphincterotomy (LIS) under spinal anesthesia in patients with chronic anal fissure. The study will evaluate wound healing rates, postoperative pain, return to work, anal incontinence, and recurrence. A total of 160 patients will be randomized equally to either closed LIS or open LIS. The primary outcome will be complete wound healing at 6 weeks. Secondary outcomes include pain at 24 hours measured by Visual Analog Scale (VAS), return to work (days), anal incontinence at 6 weeks and 1 year, and recurrence at 1 year. Multivariate analysis will identify independent predictors of non-healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-CLIS | Active comparator | Procedure: Closed Lateral Internal SphincterotomyClosed Lateral Internal Sphincterotomy (CLIS) under spinal anesthesia |
| Group B-OLIS | Active comparator | Procedure: Open Lateral Internal SphincterotomyOpen Lateral Internal Sphincterotomy (OLIS) under spinal anesthesia |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic anal fissure (symptoms > 6 weeks)
- Failure of conservative medical management (dietary fiber, stool softeners, topical lignocaine, and at least 4 weeks of topical glyceryl trinitrate 0.2%)
- Willing to provide informed consent
Key exclusion criteria (6 listed)
- Multiple fissures
- Concomitant anorectal pathology (anal fistula, abscess, significant hemorrhoids, rectal cancer)
- Inflammatory bowel disease
- Previous anorectal surgery
- History of anoreceptive intercourse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed Lateral Internal SphincterotomyA bivalve anal retractor will be inserted to visualize the intersphincteric groove. A number 11 scalpel blade will be introduced into the intersphincteric groove in the left lateral position, advanced to the level of the dentate line, and then rotated medially to divide the internal anal sphincter. A dry gauze wick soaked with xylocaine gel will be placed in the anal canal for hemostasis and removed on the evening of the operation day. | Procedure or surgery | Group A-CLIS |
| Open Lateral Internal SphincterotomyA 1-2 cm curvilinear incision will be made in the intersphincteric groove in the left lateral position. The intersphincteric plane will be dissected to expose the internal anal sphincter, which will then be divided under direct vision up to the level of the dentate line. The wound will be left open to heal by secondary intention. | Procedure or surgery | Group B-OLIS |
Primary outcome
Number of Patients with complete wound healing
Time frame: 6 weeks
Defined as evidence of scarring at the fissure site
Anal incontinence
Time frame: 6 weeks
Wexner Continence Grading Scale
3 secondary outcomes
Pain score
Time frame: 24 hours
Return to work in days
Time frame: 2 weeks
Recurrence
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Informed consent did not explicitly include permission for sharing de-identified data with external researchers Institutional ethical approval was obtained only for the primary analysis and publication, not for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Awais Amjad Malik, MBBS, FCPS study director
Services Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Lateral Internal Sphincterotomy and Open Lateral Internal Sphincterotomy in people with Chronic Anal Fissure, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with complete wound healing (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.