Weindelmayer Jacopo, Mengardo Valentina, Ascari Filippo, Baiocchi Gian Luca, Casadei Riccardo, De Palma Giovanni Domenico, De Pascale Stefano, Elmore Ugo, Ferrari Giovanni Carlo, Framarini Massimo, Gelmini Roberta, Gualtierotti Monica, Marchesi Federico, Milone Marco, Puca Lucia, Reddavid Rossella, Rosati Riccardo, Solaini Leonardo, Torroni Lorena, Totaro Luigi, Veltri Alessandro, Verlato Giuseppe, de Manzoni Giovanni
General and Upper GI Surgery Division, Azienda Ospedaliera Universitaria Integrata, Borgo Trento, Verona, Italy.
Digestive Surgery, European Institute of Oncology, Scientific Institute for Research, Hospitalization and Healthcare, Milano, Italy.
JAMA Surg. 2025 Feb 1;160(2):135-143. doi: 10.1001/jamasurg.2024.5227.
Evidence suggests that prophylactic abdominal drainage after gastrectomy for cancer may reduce postoperative morbidity and hospital stay but this evidence comes from small studies with a high risk of bias. Further research is needed to determine whether drains safely meet their primary purpose of identifying and managing postoperative intraperitoneal collections without the need for reoperation or additional percutaneous drainage.
To determine whether avoiding routine abdominal drainage increased postoperative invasive procedures.
DESIGN, SETTING, AND PARTICIPANTS: The Abdominal Drain in Gastrectomy (ADIGE) Trial was a multicenter prospective randomized noninferiority trial. Enrollment spanned from December 2019 to January 2023. Follow-up evaluations were completed at 30 and 90 days. Eleven centers within the Italian Research Group for Gastric Cancer, encompassing both academic medical centers and community hospitals, were included. Patients with gastric cancer undergoing subtotal or total gastrectomy with curative intent were eligible, excluding those younger than 18 years, with serious comorbidities, or undergoing procedure types outside the scope of the study. Of 803 patients assessed for eligibility, 404 were randomized and 390 were included in final analyses.
Patients were randomized 1:1 into prophylactic drain or no drain arms.
The primary end point was a modified intention-to-treat (mITT) analysis measuring reoperation or percutaneous drainage within 30 postoperative days. The null hypothesis was rejected when the 90% CI upper limit of the proportion difference did not exceed 3.56%. The calculated sample size to achieve 80% power with a 10% dropout rate was 404 patients (202 in each group). Surgeons and patients were blinded until gastrointestinal reconstruction.
Of the 404 patients randomized 226 (57.8%) were male; the median (IQR) age was 71 (62-78) years. Intraoperative identification of nonresectable disease occurred in 14 patients, leading to their exclusion from the study, leaving 390 patients. In the mITT analysis, 15 patients (7.7%) in the drain group needed reoperation or percutaneous drainage by postoperative day 30 vs 29 (15%) in the no drain group, favoring the drain group (difference, 7.2%; 90% CI, 2.1-12.4; P = .02). Of note, the difference in the primary composite end point was entirely due to a similar difference in reoperation (5.1% in the drain group vs 12.4% in the no drain group; P = .01). Drain-related complications occurred in 4 patients.
The findings of this study indicate that refraining from prophylactic drain use after gastrectomy heightened the risk of postoperative invasive procedures, discouraging its avoidance. Future studies identifying high-risk groups could optimize prophylactic drainage decisions.
ClinicalTrials.gov Identifier: NCT04227951.
有证据表明，癌症胃切除术后预防性腹腔引流可能会降低术后发病率和缩短住院时间，但这一证据来自存在高偏倚风险的小型研究。需要进一步研究以确定引流管能否安全实现其识别和处理术后腹腔积液的主要目的，而无需再次手术或额外的经皮引流。
确定避免常规腹腔引流是否会增加术后侵入性操作。
设计、设置和参与者：胃切除术中腹腔引流（ADIGE）试验是一项多中心前瞻性随机非劣效性试验。入组时间为2019年12月至2023年1月。在30天和90天时完成随访评估。意大利胃癌研究组内的11个中心被纳入，包括学术医疗中心和社区医院。符合条件的患者为有治愈意图的接受次全或全胃切除术的胃癌患者，排除年龄小于18岁、有严重合并症或接受研究范围外手术类型的患者。在803名评估是否符合条件的患者中，404名被随机分组，390名被纳入最终分析。
患者按1:1随机分为预防性引流组或无引流组。
主要终点是改良意向性治疗（mITT）分析，测量术后30天内的再次手术或经皮引流情况。当比例差异的90%置信区间上限不超过3.56%时，原假设被拒绝。在10%失访率的情况下，为达到80%检验效能计算的样本量为404名患者（每组202名）。在胃肠道重建前，外科医生和患者均处于盲态。
在404名随机分组的患者中，226名（57.8%）为男性；年龄中位数（IQR）为71（62 - 78）岁。14名患者术中被确定为不可切除疾病，导致其被排除在研究之外，剩余390名患者。在mITT分析中，引流组有15名患者（7.7%）在术后第30天需要再次手术或经皮引流，而无引流组为29名（15%），引流组更具优势（差异为7.2%；90%置信区间为2.1 - 12.4；P = 0.02）。值得注意的是，主要复合终点的差异完全是由于再次手术的类似差异（引流组为5.1%，无引流组为12.4%；P = 0.01）。4名患者发生了与引流相关的并发症。
本研究结果表明，胃切除术后不使用预防性引流会增加术后侵入性操作风险，不鼓励避免使用。未来识别高危人群的研究可能会优化预防性引流决策。
ClinicalTrials.gov标识符：NCT04227951。
