Cessation vs no cessation of acetylsalicylic acid preoperatively in laparoscopic totally extraperitoneal inguinal hernia repair (CAPTAIN): final report from a multi-center, single-blinded, randomized-controlled trial.

Abstract

Title: Cessation vs No Cessation of Acetylsalicylic acid Preoperatively in Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair (CAPTAIN): Final Report from a Multi-Center, Single-Blinded, Randomized-Controlled Trial. The CAPTAIN trial is a prospective multi-center randomized-controlled trial evaluating the safety of continuing acetylsalicylic acid preoperatively in patients undergoing elective laparoscopic inguinal hernia mesh repair (LIHR).

Methods: Patients undergoing LIHR were eligible for inclusion. Patients unfit for general anesthesia, patients who had obstructed hernias or patients who underwent open operation were excluded. Participants were randomized by the trial coordinator using allocation concealment to either acetylsalicylic acid-cessation or continuation group, without the surgeon knowing.

Outcome: Primary outcome was the incidence of bleeding complications evidenced by the presence of postoperative hematomas before the patient was discharged from hospital. Secondary outcomes include incidence of major cardiovascular events, post-operative thromboembolic events, seroma formation and length of hospital stay.

Results: 100 patients were recruited between April 2016 and June 2024. 5 patients were excluded because they 3 underwent open operation, 1 withdrew consent and 1 had their operation cancelled, leaving 45 patients in the acetylsalicylic acid-continuation group and 50 patients in the cessation group.

Outcomes: We found that significantly more patients who continued acetylsalicylic acid had hematomas in the index admission (11 vs 5, p = 0.018). There was no difference in the amount of intraoperative blood loss between the two groups, 12.9 vs 9.3ml (p = 0.130). Both groups of patients had short postoperative stay-an average of less than a day. There were no postoperative thromboembolic events or major adverse cardiac events in either group. The rates of postoperative seroma were similar between both groups, 28.9% vs 26% (p = 0.755). At 30 days post operation, there were no hernia recurrence or readmissions in either group.

Conclusion: The increase in the rate of postoperative hematomas formation in the acetylsalicylic acid-continuation group though statistically significant; was not clinically significant as no blood transfusion was required and all hematomas resolved with conservative management by 90-days clinic review despite no cessation of acetylsalicylic acid. Thus, this randomized-controlled trial concludes that it is safe to continue acetylsalicylic acid perioperatively in selected patients undergoing LIHR. Larger scale randomized-controlled trials would be helpful to corroborate these findings.

Trial registration: Ethics approval was obtained from our healthcare cluster's Domain Specific Review Board (reference number 2015/00512). The study protocol was registered on ClinicalTrials.gov (registration number NCT02604732).