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Randomized Controlled Trial
. 2023 Dec 29;409(1):23.
doi: 10.1007/s00423-023-03212-9.

Efficacy of rectal indomethacin in prevention of post-operative hyperamylasemia following pancreatoduodenectomy: a randomized controlled trial

Anubhav Harshit Kumar  1 , Viniyendra Pamecha  2 , Nilesh Sadashiv Patil  1 , Nihar Mohapatra  1 , Ragini Kilambi  1 , Piyush Kumar Sinha  1
Affiliations
Randomized Controlled Trial

Efficacy of rectal indomethacin in prevention of post-operative hyperamylasemia following pancreatoduodenectomy: a randomized controlled trial

Anubhav Harshit Kumar et al. Langenbecks Arch Surg. .

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.

Keywords: Pancreatoduodenectomy; Post-operative hyperamylasemia; Rectal indomethacin.

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