Prophylactic use of anastomotic 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 Randomized Controlled Trials (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, Enhanced Recovery After Surgery (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. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
404
In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.
In Drain arm (sham comparator) an abdominal drain is inserted in the abdomen from the right flank, passing below the liver (close to the duodenal stump) with the apex behind the esophago-jejunal (in total gastrectomy) or gastro-jejunal (in subtotal gastrectomy) anastomosis.
Ospedale Morgagni di Forlì - Chirurgia generale
Forlì, Forlì-Cesena, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale
Orbassano, Torino, Italy
Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica
Bergamo, Italy
Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale
Bologna, Italy
Ospedale di Cremona
Cremona, Italy
Ospedale San Raffaele - Chirurgia Gastroenterologica -
Milan, Italy
ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva
Milan, Italy
Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza
Modena, Italy
Ospedale Federico II di Napoli- Chirurgia Generale
Naples, Italy
Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale
Parma, Italy
...and 1 more locations
30 day reoperation AND/OR additional drain placement
Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)
Time frame: 30 days after the operation
Overall mortality
Time frame: 90 days after the operation
Overall morbidity
Complications are classified according to International consensus on a complications list after gastrectomy for cancer - Baiocchi et Al, Gastric Cancer, 2019 and stratified according to Clavien-Dindo classification.
Time frame: 30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization
Length of hospital stay
Time frame: From the day of operation until discharge (home or other facilities) or death for any cause whichever came first, assessed up to 100 months.
Drain related complications
Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded
Time frame: From the day of operation until drain removal up to 90 days after the operation
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