Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Standard Medical Treatment
- Conditions
- Pancreatoduodenectomy
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Post-operative Pancreatitis
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All consenting adults planned to undergo pancreatoduodenectomy,
Exclusion Criteria
- •allergic reactions to NSAIDs
- •internal hemorrhoids
- •anti-platelet medications
Arms & Interventions
Group B
Standard Medical Treatment
Intervention: Standard Medical Treatment
Group A
Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
Intervention: Indomethacin suppository
Group A
Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
Intervention: Standard Medical Treatment
Outcomes
Primary Outcomes
Post-operative Pancreatitis
Time Frame: first 30 days following pancreatoduodenectomy
Secondary Outcomes
- intra-abdominal abscess(first 30 days following pancreatoduodenectomy)
- Length of ICU stay(First 30 days following pancreatoduodenectomy)
- Post-operative Pancreatic Fistula(first 30 days following pancreatoduodenectomy)
- delayed gastric emptying(First 30 days following pancreatoduodenectomy)
- Length of hospital stay(First 30 days following pancretoduodenectomy)
- risk factors of post-operative pancreatitis(first 30 days following pancreatoduodenectomy)