Published in:
01-12-2024 | Indomethacin | Research
Efficacy of rectal indomethacin in prevention of post-operative hyperamylasemia following pancreatoduodenectomy: a randomized controlled trial
Authors:
Anubhav Harshit Kumar, Viniyendra Pamecha, Nilesh Sadashiv Patil, Nihar Mohapatra, Ragini Kilambi, Piyush Kumar Sinha
Published in:
Langenbeck's Archives of Surgery
|
Issue 1/2024
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Abstract
Background
Post-operative hyperamylasemia (POH) following pancreatoduodenectomy (PD) may play a key role in pathogenesis of post-operative pancreatic fistula (POPF). Aim of the current study was to evaluate efficacy of perioperative administration of indomethacin in preventing POH.
Methods
Single-center, double-blind, randomized controlled trial (RCT) conducted on consecutive patients undergoing PD. Patients received either 100 mg of indomethacin per-rectally at induction of anesthesia or standard care. Primary endpoint was incidence of POH in the two arms. POH was defined as postoperative day (POD) 1 serum amylase (S. amylase) levels greater than the upper limit of normal.
Results
After exclusion 44 patients were randomized. The two arms were comparable for preoperative and intraoperative parameters. POH was noted in 20/44 (45.5%) with significantly lower incidence of POH (60.9% vs. 28.6%, p = 0.032) in intervention arm (IA). Median S. amylase, POD 1, 3, and 5 drain amylase, and incidence of clinically relevant POPF (CR-POPF) were lower in IA but failed to reach statistical significance (30.4% vs. 14.3%, p = 0.18). The severity of delayed gastric emptying (DGE) was significantly lower in the IA (grade B/C DGE 23.8% vs. 47.8%, p = 0.023). Evaluation of risk factors for POH showed IA to confer an independent protective effect and increased risk with soft pancreas.
Conclusion
Perioperative per-rectal indomethacin administration is effective in decreasing the incidence of POH following pancreatoduodenectomy.