Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

Abstract Background Prophylactic use of abdominal drain in gastrectomy has been questioned the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to routine placement gastrectomy. Nevertheless, authors evidenced moderate/low quality included studies highlighted how 3 out 4 came from Eastern countries. After 2015, only retrospective have published, all with inconsistent results. Methods ADiGe (Abdominal Drain Gastrectomy) Trial is multicenter prospective randomized non-inferiority trial parallel design. It aimed verify whether avoiding burdened complications, particularly an increase postoperative invasive procedures. Patients gastric cancer, scheduled for subtotal or total curative intent, are eligible inclusion, irrespective previous oncological treatment. The primary composite endpoint reoperation percutaneous drainage procedures within 30 days. analysis will incidence higher experimental arm, placement, than control undergoing prophylactic order falsify support null hypothesis inferiority. Secondary endpoints assessed superiority overall morbidity mortality, Comprehensive Complications Index, time diagnosis anastomotic duodenal leaks, length hospital stay, readmission rate. Assuming one-sided alpha 5%, cumulative 6.4% arm 4.2% one, 364 patients allow achieve 80% power detect margin difference between proportions 3.6%. Considering 10% drop-out rate, 404 needed. In balanced percentage gastrectomy, recruitment end at 202 each type surgeon patient blinded until operation, while course not caregivers. Discussion could contribute critically re-evaluate role still widely used procedure. registration Prospectively registered (last updated 29 October 2020) ClinicalTrials.gov identifier NCT04227951 .