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Nitroglycerine ointment- does it prevent anal injury

Does topical nitroglycerine protect the anal sphincter in patients undergoing transanal stapled anastomosis?

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/01/003293
Enrollment
80
Registered
2013-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- The anatomy and function of the anal sphincter

Interventions

Intervention1: Application of 0.2% nitroglycerine ointment: 1/2 inch of 0.2% nitroglycerine ointment is applied into the anus a minute before the insertion of an endoanal circular stapler in patients

Sponsors

Christian Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients planned for trans anal anastomosis using an endoanal stapler device under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients known or suspected to have cardiovascular disorders like cardiomyopathies, heart failure and recent myocardial infarction. 2. Previous anal canal operations done for fistulae or the sphincter. 3. Previous anal, perianal and intersphincteric abscess. 4. Neurological disorders which cause anal dysfunction.

Design outcomes

Primary

MeasureTime frame
The post operative maximal resting pressure of the anal sphincter.Timepoint: Three months post operative period.

Secondary

MeasureTime frame
1.The drop in maximal resting pressure of the anal sphincter. 2.Injury to the anal sphincter as assessed by the endoanal ultrasound. 3.Fecal incontinence score (Kamms score)Timepoint: Preoperative and three months post operative period.

Countries

India

Contacts

Public ContactDorcas Grace

Christian Medical College and Hospital

markranjan@hotmail.com09486843884

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026