Propensity score-matched analysis comparing drains and no-drains in rectal cancer surgery: the value of using a hemostatic agent instead. A prospective observational study

Abstract

Background: This study evaluates the efficacy of Microporous Polysaccharide Hemospheres (MPH) as an alternative to prophylactic drains in rectal cancer surgery. We hypothesize that MPH reduces postoperative complications by minimizing fluid accumulation and associated risks, thereby improving outcomes within enhanced recovery protocols (ERP).

Methods: A prospective, multicenter observational study was conducted from January 2020 to January 2024, including adult patients undergoing high or low rectal resection for rectal cancer. Patients receiving MPH were compared to matched controls from the IMPRICA database who either received prophylactic drains or no drainage. Propensity score matching was employed to mitigate selection bias. Outcomes were assessed within the 30 postoperative days, focusing on surgical and medical complications.

Results: From a cohort of 3,725 patients, 90 received MPH without drainage, 2,806 underwent surgery with prophylactic drains, and 829 had no drains. Between 2020 and 2024, surgical complications were significantly lower in the MPH group (12.2%) compared to the drain group (26.2%) and comparable to the no-drain group (20.6%). The odds of complications in the MPH group were reduced by nearly half respect to the no-drain group (OR: 0.54 [95% CI: 0.27-1.08]). MPH was associated with fewer anastomotic leaks, hemorrhages, and surgical site infections, and no adverse effects were reported.

Conclusion: This study provides evidence that prophylactic drains are not only unnecessary but may also be potentially harmful in rectal surgery. The application of MPH offers a safe and effective alternative to improve postoperative outcomes. These findings support a shift toward eliminating drains in favor of innovative solutions aligned with ERP principles.

Keywords: enhanced recovery protocols (ERP); postoperative complications; prophylactic drains; prospective multicenter observational study; rectal surgery.