Avoiding Prophylactic Drains After Gastrectomy Increases Risk of Postoperative Complications: ADIGE Trial

For this purpose, the researchers conducted the ADIGE Trial, a multicenter, prospective randomized noninferiority study. The trial included 404 patients with gastric cancer undergoing subtotal or total gastrectomy, recruited from 11 centers in Italy between December 2019 and January 2023. Participants were randomized into two groups: prophylactic drain or no drain.

The primary outcome was reoperation or percutaneous drainage within 30 days post-surgery, analyzed through a modified intention-to-treat approach. The study aimed to test if avoiding drains increased the need for invasive procedures, with surgeons and patients blinded until gastrointestinal reconstruction.

The trial revealed the following findings:

• Of the 404 patients randomized, 226 (57.8%) were male, with a median age of 71 years.
• Fourteen patients were excluded due to intraoperative identification of nonresectable disease, leaving 390 patients for analysis.
• In the modified intention-to-treat (mITT) analysis, 7.7% of patients in the drain group required reoperation or percutaneous drainage by day 30, compared to 15% of patients in the no-drain group, favoring the drain group (difference 7.2%).
• The primary difference was due to a lower reoperation rate in the drain group (5.1%) compared to the no-drain group (12.4%).
• Drain-related complications occurred in 4 patients.

"These findings indicate that avoiding drains may raise the risk of postoperative complications, especially invasive procedures, in this patient population. Future research identifying high-risk groups could help refine decisions regarding prophylactic drainage," the researchers concluded.

Reference:

Weindelmayer J, Mengardo V, Ascari F, et al. Prophylactic Drain Placement and Postoperative Invasive Procedures After Gastrectomy: The Abdominal Drain After Gastrectomy (ADIGE) Randomized Clinical Trial. JAMA Surg. Published online November 27, 2024. doi:10.1001/jamasurg.2024.5227