General and Upper G.I. Surgery Division, Azienda Ospedaliera Universitaria Integrata, Piazzale Aristide Stefani 1, Borgo Trento, 37126, Verona, Italy.
Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Trials. 2021 Feb 17;22(1):152. doi: 10.1186/s13063-021-05102-1.
Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015, only retrospective studies have been published, all with inconsistent results.
ADiGe (Abdominal Drain in Gastrectomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to the patient and caregivers.
ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.
Prospectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951 .
在过去的 15 年中，人们对胃切除术中预防性使用腹部引流管提出了质疑，2015 年 Cochrane 荟萃分析对四项 RCT 进行了评估，得出的结论是，没有令人信服的证据支持常规放置引流管用于胃切除术。然而，作者指出纳入研究的质量为中低质量，并强调了其中 4 项研究中有 3 项来自东方国家。2015 年后，仅发表了回顾性研究，结果均不一致。
ADiGe（胃切除术中的腹部引流管）试验是一项多中心前瞻性随机非劣效性试验，采用平行设计。旨在验证避免常规使用腹部引流管是否会带来并发症，特别是增加术后侵入性操作。接受根治性胃大部或全胃切除术的胃癌患者符合纳入标准，无论之前是否接受过肿瘤治疗。主要复合终点是术后 30 天内再次手术或经皮引流术。主要分析将验证在实验组中，避免常规引流管放置是否比对照组（预防性引流管放置）更容易发生术后并发症，从而否定或支持无效假设的劣势。评估优势的次要终点是总发病率和死亡率、综合并发症指数、吻合口和十二指肠漏的诊断发生率和时间、住院时间和再入院率。假设单侧 α 值为 5%，对照组主要复合终点累积发生率为 6.4%，实验组为 4.2%，则需要 364 例患者才能达到 80%的效能来检测两组之间的非劣效性差异为 3.6%。考虑到 10%的脱落率，需要 404 例患者。为了使全胃切除术和胃大部切除术的患者人数保持平衡，每种类型的胃切除术将各招募 202 例患者。手术医生和患者在手术结束前处于盲态，而患者和护理人员在术后过程中无法处于盲态。
ADiGe 试验可能有助于重新评估预防性引流管在胃切除术中的作用，这仍然是一种广泛应用的术式。
前瞻性注册（最后更新日期为 2020 年 10 月 29 日）于 ClinicalTrials.gov，标识符为 NCT04227951。
