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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial

Conditions
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Pancreatoduodenectomy

Intervention / Treatment
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* Drug: Indomethacin suppository
* Other: Standard Medical Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting adults planned to undergo pancreatoduodenectomy, Exclusion Criteria: asthma allergic reactions to NSAIDs CKD internal hemorrhoids anti-platelet medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group B<br>Standard Medical Treatment | Other: Standard Medical Treatment<br>* Standard Medical Treatment<br>|
| Experimental: Group A<br>Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment | Drug: Indomethacin suppository<br>* 100mg Indomethacin Suppository administered at the time of Induction<br>Other: Standard Medical Treatment<br>* Standard Medical Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pancreatitis |  | first 30 days following pancreatoduodenectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pancreatic Fistula |  | first 30 days following pancreatoduodenectomy | 
| delayed gastric emptying |  | First 30 days following pancreatoduodenectomy | 
| intra-abdominal abscess |  | first 30 days following pancreatoduodenectomy | 
| Length of ICU stay |  | 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 |