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Does local application of nitrates, during insertion of staplers via anal canal for bowel anastomosis prevent injury to muscles of anal canal ?

Role of topical nitrates in prevention of anal sphincter injury during transanal stapled anastomosis â?? a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008836
Enrollment
42
Registered
2017-06-14
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- All patients planned for colorectal anastomosis using transanal stapler Health Condition 2: C20- Malignant neoplasm of rectum

Interventions

Intervention1: 0.2% Glyceryl Trinitrate: 1mg 0.2% glyceryl trinitrate, which corresponds to 2cm on the standardized measuring scale Control Intervention1: Nil: Nil

Sponsors

Christian Medical College and Hospital Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients planned for colorectal anastomosis using transanal stapler.

Exclusion criteria

Exclusion criteria: Patients Patient who have undergone previous perianal procedures. Patient on Nitrates/Calcium Channel Blockers

Design outcomes

Primary

MeasureTime frame
To compare anal sphincter pressure between intervention and observation groupsTimepoint: 1-3 days preoperative and 14-30 days postoperative

Secondary

MeasureTime frame
To compare wexner incontinence scoresTimepoint: 1-3 days preoperative and 14-30 days postoperative

Countries

India

Contacts

Public ContactMark Ranjan Jesudason

Christian Medical College, Vellore

ranjanbernice@cmcvellore.ac.in04162282159

Outcome results

None listed

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