Efficacy of Rectal Indomethacin in prevention of post-operative pancreatitis after pancreaticoduodenectomy – a randomized controlled trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Incidence of Post-operative Pancreatitis
Study Overview
Brief Summary
Pancreatico-duodenectomy is one of the commonly performed procedure for
periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an
emerging concept, recently being studied as one of the most important contributing factor of
Post-operative pancreatic fistula, which is one of the major complication of
pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug,
when given in a single dose has been shown to prevent pancreatitis in patients undergoing
ERCP. In this study, we will be administering rectal indomethacin at the time of induction of
anesthesia to the experimental arm of the study and compare the results in terms of incidence of
post-operative pancreatitis in the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All consenting adults planned to undergo pancreatoduodenectomy.
Exclusion Criteria
- •Patients refusing to consent
- •History of asthma
- •History of allergic reactions to NSAIDs
- •History of renal dysfunction or CKD
- •E/o Internal hemorrhoids on examination
- •Patients on Anti-platelet drugs.
Outcomes
Primary Outcomes
Incidence of Post-operative Pancreatitis
Time Frame: Within 30 days of surgery
Secondary Outcomes
- Post-operative pancreatic fistula rate(within 30 days of surgery)
- Post-pancreaticoduodenectomy hemorrhage rate(within 30 days of surgery)
- Delayed Gastric emptying rate(within 30 days of surgery)
- Intra-abdominal collections/abscess rates(within 30 days of surgery)
- Duration of ICU stay(within 30 days of surgery)
- Length of Hospital Stay(within 30 days of surgery)
- Risk factors for post-operative pancreatitis(within 30 days of surgery)