Prophylactic use of abdominal drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four RCT concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, ERAS society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. ADiGe (Abdominal Drain in Gastrectomy) Trial is a multi-centre prospective trial in a large western cohort of patients to establish wether avoid routine use of abdominal drain does not led to an increased number of postoperative invasive procedure.
Primary Endpoint:
Compare the incidence of patients that require reoperation OR percutaneous drainage procedures within 30 postoperative days (composite endpoint) between drain group and no drain group. Enrolment is set to achieve a non-inferiority outcome.
Secondary Endpoints:
Compare the two groups in term of:
- Incidence, severity and time to diagnosis of anastomotic and duodenal leak;
- Length of hospital stays;
- Overall 30 days morbidity (OR in hospital if longer than 30 days) classified according to the international consensus on a complications list after gastrectomy for cancer (Baiocchi et Al, Gastric Cancer, 2019) and stratified using the Clavien Dindo classification;
- Overall 90 days mortality;
- 30 days readmission rate;
- Drain related complications (drain group only)
Adige Trial Committee
G. de Manzoni, J. Weindelmayer, V. Mengardo, A, Veltri