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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Pancreatoduodenectomy

Treatments: Drug: Indomethacin suppository; Other: Standard Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05109143

IEC/2020/81/MA13

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Group B

Active Comparator group

Description:

Standard Medical Treatment

Treatment:

Other: Standard Medical Treatment

Group A

Experimental group

Description:

Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

Treatment:

Drug: Indomethacin suppository

Other: Standard Medical Treatment