Chronic Anal FissureNCT07884916
Topical Nitroglycerin Versus Lateral Internal Sphincterotomy for Chronic Anal Fissure
A study testing Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) Ointment and Lateral Internal Sphincterotomy in people with Chronic Anal Fissure, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) Ointment and Lateral Internal Sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2026to 14 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaikh Zayed Hospital, General Surgery and Surgical Oncology, Unit-2
Lahore, Punjab Province
About this study
Official title: Comparison Between Topical Nitroglycerin Versus Lateral Internal Sphincterotomy as Treatment of Chronic Anal Fissure: A Randomized Controlled Trial
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.
Read the detailed description
This is a randomized controlled trial to compare topical nitroglycerin and lateral internal sphincterotomy in patients aged 18-65 years with clinically diagnosed chronic anal fissure persisting for more than six weeks.
Eligible participants presenting to the Department of General Surgery and Surgical Oncology, Unit-2, Shaikh Zayed Hospital, Lahore, will be assessed against predefined inclusion and exclusion criteria. Following informed written consent, participants will be allocated to one of two groups using the lottery method described in the study protocol.
Group A will receive 0.2% topical glyceryl trinitrate (nitroglycerin) ointment in a liposomal base, applied twice daily for six weeks. Group B will undergo standard open lateral internal sphincterotomy.
Follow-up assessments will take place on Day 7 and at Weeks 2, 3, 4 and 8. Pain will be measured using the 10-point Visual Analogue Scale. Clinical examination will assess fissure healing.
Time to pain relief is defined in the protocol as the number of days from treatment initiation until the VAS score is 3 or less at two consecutive follow-up visits. Time to healing is defined as the number of days from treatment initiation until complete epithelialization, with no bleeding and no pain during defecation, confirmed by clinical examination.
The study will compare pain-relief time and healing time between the two treatment groups. Data will be analyzed using SPSS, with independent-samples t-tests or Mann-Whitney U tests for continuous outcomes as appropriate, and chi-square or Fisher's exact tests for categorical outcomes.
- Conditions
- Chronic Anal Fissure
- Being tested
- Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) Ointment, Lateral Internal Sphincterotomy
- Keywords
- Anal Fissure, Chronic anal fissure, Nitroglycerin, Glyceryl Trinitrate, Pain Relief, Fissure Healing, Lateral internal sphincterotomy, Randomized controlled trial
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Lateral Internal SphincterotomyProcedure or surgery
Lateral internal sphincterotomy performed surgically for the treatment of chronic anal fissure.
| Study group | Role | What they receive |
|---|---|---|
| Topical Nitroglycerin Group | Experimental | Topical 0.2% glyceryl trinitrate ointment in a liposomal base, applied to the anoderm twice daily for six weeks. Receives: 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. Receives: Procedure: Lateral Internal Sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From treatment initiation through the final planned follow-up at Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Jun 2026
- Primary completion14 Sep 2026
- Study completion14 Sep 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaigham Jameel, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884916
- Sponsor's protocol ID
- TERC/SC/INT/2025/313
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Topical Nitroglycerin Versus Lateral Internal Sphincterotomy as Treatment of Chronic Anal Fissure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07884916
- Acronym / sponsor ID
- TERC/SC/INT/2025/313
- Conditions
- Chronic Anal Fissure
- Keywords
- Anal Fissure, Chronic anal fissure, Nitroglycerin, Glyceryl Trinitrate, Pain Relief, Fissure Healing, Lateral internal sphincterotomy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 21 Oct 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.
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.
Detailed description
This is a randomized controlled trial to compare topical nitroglycerin and lateral internal sphincterotomy in patients aged 18-65 years with clinically diagnosed chronic anal fissure persisting for more than six weeks.
Eligible participants presenting to the Department of General Surgery and Surgical Oncology, Unit-2, Shaikh Zayed Hospital, Lahore, will be assessed against predefined inclusion and exclusion criteria. Following informed written consent, participants will be allocated to one of two groups using the lottery method described in the study protocol.
Group A will receive 0.2% topical glyceryl trinitrate (nitroglycerin) ointment in a liposomal base, applied twice daily for six weeks. Group B will undergo standard open lateral internal sphincterotomy.
Follow-up assessments will take place on Day 7 and at Weeks 2, 3, 4 and 8. Pain will be measured using the 10-point Visual Analogue Scale. Clinical examination will assess fissure healing.
Time to pain relief is defined in the protocol as the number of days from treatment initiation until the VAS score is 3 or less at two consecutive follow-up visits. Time to healing is defined as the number of days from treatment initiation until complete epithelialization, with no bleeding and no pain during defecation, confirmed by clinical examination.
The study will compare pain-relief time and healing time between the two treatment groups. Data will be analyzed using SPSS, with independent-samples t-tests or Mann-Whitney U tests for continuous outcomes as appropriate, and chi-square or Fisher's exact tests for categorical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Nitroglycerin Group | Experimental | Drug: Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) OintmentTopical 0.2% glyceryl trinitrate ointment in a liposomal base, applied to the anoderm twice daily for six weeks. |
| Lateral Internal Sphincterotomy | Active comparator | Procedure: Lateral Internal SphincterotomyStandard open lateral internal sphincterotomy, as described in the approved study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) OintmentTopical 0.2% glyceryl trinitrate (nitroglycerin) ointment applied locally twice daily for 6 weeks for the treatment of chronic anal fissure. | Drug | Topical Nitroglycerin Group |
| Lateral Internal SphincterotomyLateral internal sphincterotomy performed surgically for the treatment of chronic anal fissure. | Procedure or surgery | Lateral Internal Sphincterotomy |
Primary outcome
Time to Pain Relief
Time frame: From treatment initiation through the final planned follow-up at Week 8.
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.
Time to Complete Healing of Chronic Anal Fissure
Time frame: From treatment initiation through the final planned follow-up at Week 8.
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.
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 21 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) Ointment and Lateral Internal Sphincterotomy in people with Chronic Anal Fissure, run by Sheikh Zayed Federal Postgraduate Medical Institute 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 1 inclusion and 1 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 21 Oct 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?
Time to Pain Relief (time frame: From treatment initiation through the final planned follow-up at Week 8.). 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 21 Oct 2026.