ADIGE
Trial question
What is the role of prophylactic abdominal drainage in patients with gastric cancer undergoing subtotal or total gastrectomy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 390
390 patients (164 female, 226 male).
Inclusion criteria: adult patients with nonmetastatic gastric cancer undergoing subtotal or total gastrectomy.
Key exclusion criteria: age < 18 years; serious comorbidities; emergency surgery; palliative surgery; multiple organ resections; gastric cancer with duodenal involvement; intraoperative hyperthermic intraperitoneal chemotherapy.
Interventions
N=196 prophylactic drainage (a drain passed by the duodenal stump with the apex posterior to the anastomosis).
N=194 no drainage (no drain palcement).
Primary outcome
Rate of reoperation or percutaneous drainage within 30 days
7.7%
15%
15.0 %
11.3 %
7.5 %
3.8 %
0.0 %
Prophylactic
drainage
No
drainage
Significant
decrease ▼
NNT = 13
Significant decrease in the rate of reoperation or percutaneous drainage within 30 days (7.7% vs. 15%; ARD -7.2, 90% CI -12.4 to -2.2).
Secondary outcomes
No significant difference in death at day 90 (4.1% vs. 8.8%; ARD -4.7, 95% CI -9.61 to 0.21).
Significant decrease in death in the hospital prior to discharge (0.5% vs. 4.6%; ARD -4.1, 95% CI -7.81 to -0.39).
Safety outcomes
No significant difference in medical complications.
Significant difference in acute kidney insufficiency (0% vs. 3%).
Conclusion
In adult patients with nonmetastatic gastric cancer undergoing subtotal or total gastrectomy, prophylactic drainage was superior to no drainage with respect to the rate of reoperation or percutaneous drainage within 30 days.
Reference
Jacopo Weindelmayer, Valentina Mengardo, Filippo Ascari et al. Prophylactic Drain Placement and Postoperative Invasive Procedures After Gastrectomy: The Abdominal Drain After Gastrectomy (ADIGE) Randomized Clinical Trial. JAMA Surg. 2025 Feb 1;160(2):135-143.
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