NCT07884916

Brief Summary

Chronic anal fissure is a tear in the lining of the anal canal that can cause pain during and after defecation. This randomized controlled trial will compare topical 0.2% nitroglycerin ointment with lateral internal sphincterotomy in adults with chronic anal fissure. A total of 72 eligible participants will be allocated to one of two treatment groups. The nitroglycerin group will receive topical treatment twice daily for six weeks, while the surgical group will undergo lateral internal sphincterotomy. Participants will be assessed at Day 7 and Weeks 2, 3, 4 and 8. The study will compare the time required for pain relief and complete fissure healing between the two treatment groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 13, 2026

Last Update Submit

October 13, 2026

Conditions

Chronic Anal Fissure

Keywords

Anal FissureChronic anal fissureNitroglycerinGlyceryl TrinitratePain ReliefFissure HealingLateral internal sphincterotomyRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Time to Pain Relief

    Number of days from initiation of treatment until the participant's Visual Analogue Scale pain score is 3 or less at two consecutive follow-up visits.

    From treatment initiation through the final planned follow-up at Week 8.

  • Time to Complete Healing of Chronic Anal Fissure

    Number of days from initiation of treatment until complete epithelialization of the fissure, with no bleeding and no pain during defecation, confirmed by clinical examination.

    From treatment initiation through the final planned follow-up at Week 8.

Study Arms (2)

Topical Nitroglycerin Group

EXPERIMENTAL

Topical 0.2% glyceryl trinitrate ointment in a liposomal base, applied to the anoderm twice daily for six weeks.

Drug: Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) Ointment

Lateral Internal Sphincterotomy

ACTIVE COMPARATOR

Standard open lateral internal sphincterotomy, as described in the approved study protocol.

Procedure: Lateral Internal Sphincterotomy

Interventions

Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) OintmentDRUG

Topical 0.2% glyceryl trinitrate (nitroglycerin) ointment applied locally twice daily for 6 weeks for the treatment of chronic anal fissure.

Topical Nitroglycerin Group
Lateral Internal SphincterotomyPROCEDURE

Lateral internal sphincterotomy performed surgically for the treatment of chronic anal fissure.

Lateral Internal Sphincterotomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years. Both male and female participants. Clinically diagnosed chronic anal fissure persisting for more than six weeks. No prior surgical treatment for anal fissure. Able to comply with the follow-up schedule.

You may not qualify if:

  • Acute anal fissure of less than six weeks' duration. Previous lateral internal sphincterotomy or anorectal surgery. Current use of topical glyceryl trinitrate or calcium channel blockers. Crohn's disease or tuberculosis. Perianal abscess or fistula. Grade III-IV hemorrhoids. Pregnancy. Known hypersensitivity to nitroglycerin. Inability or unwillingness to comply with follow-up. Failure to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital, General Surgery and Surgical Oncology, Unit-2

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Fissure in Ano

Interventions

NitroglycerinOintmentsLateral Internal Sphincterotomy

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic ChemicalsDosage FormsPharmaceutical PreparationsDigestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speciality Registrar (SPR) / Postgraduate Resident (PGR)

Study Record Dates

First Submitted

October 13, 2026

First Posted

October 21, 2026

Study Start

June 15, 2026

Primary Completion

September 14, 2026

Study Completion

September 14, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Patient-level surgical and clinical data are confidential. Sharing them requires appropriate de-identification, safeguards, and compliance with institutional ethics approval and applicable consent requirements.

Locations

PA(1)