Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatoduodenectomy
• Interventions: Drug: Indomethacin suppository; Other: Standard Medical Treatment

• Registration Number: NCT05109143
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-17
• Status Verified: 2021-10
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-05
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion Criteria

• asthma
• allergic reactions to NSAIDs
• CKD
• internal hemorrhoids
• anti-platelet medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Indomethacin suppository	Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
Group B	Standard Medical Treatment	Standard Medical Treatment
Group A	Standard Medical Treatment	Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

Primary Outcome Measures

Name	Time	Method
Post-operative Pancreatitis	first 30 days following pancreatoduodenectomy

Secondary Outcome Measures

Name	Time	Method
risk factors of post-operative pancreatitis	first 30 days following pancreatoduodenectomy
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

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India