An interventional study of Topical 0.2% Glyceryl Trinitrate (Nitroglycerin) Ointment and Lateral Internal Sphincterotomy in Chronic Anal Fissure, sponsored by Sheikh Zayed Federal Postgraduate Medical Institute. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Sheikh Zayed Federal Postgraduate Medical Institute · Not applicable, Interventional, and Treatment
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.
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.
80 studies on the registry are indexed under Fissure in Ano; 14 are open to participants now.
This study's enrollment of 72 is below the median of 99 across 62 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →Sheikh Zayed Federal Postgraduate Medical Institute is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
Standard open lateral internal sphincterotomy, as described in the approved study protocol.
Procedure: Lateral Internal Sphincterotomy
Topical 0.2% glyceryl trinitrate (nitroglycerin) ointment applied locally twice daily for 6 weeks for the treatment of chronic anal fissure.
Lateral internal sphincterotomy performed surgically for the treatment of chronic anal fissure.
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.
Time frame: 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.
Time frame: From treatment initiation through the final planned follow-up at Week 8.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topical Dosage Form
Sheikh Zayed Federal Postgraduate Medical Institute