Gastric Cancer
Conditions
Keywords
Gastrectomy, Drain, Drainage
Brief summary
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.
Interventions
DEVICEAvoid drain placement
In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.
DEVICEDrain placement
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.
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The leading surgeon and the patient will be blinded to the arm assigned until the end of the operation. No blinding is provided for the patient, care providers, or coordinating researcher after the operation. After the operation we thought that was unreliable to go ahead with participants blindness considering that one arm has an evident drain and the other arm has no drain. Considering that clinicians will need to check drain quality and remove the tube in treatment group we considered not possible to mask the care providers or investigators on this practice.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number * esophageal involvement \<= 2 cm * patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy * open, hybrid, laparoscopic or robotic approach * all types of anastomosis (circular stapled, linear stapled, hand sewn)
Exclusion criteria
* refuse to sign informed consent * age \<18 * Heart failure New York Heart Association (NYHA) class IV * severe liver disease (Child \>= 7) * pregnancy * metastatic disease * emergency surgery * palliative surgery * operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy) * lymphnodal dissection \<D1 * reconstruction different from Roux-en-Y or Billroth II * multiple organ resections (except for cholecystectomy) * gastric cancer with duodenal involvement * intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day reoperation AND/OR additional drain placement | 30 days after the operation | Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality | 90 days after the operation | — |
| Overall morbidity | 30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization | 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. |
| Length of hospital stay | 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 | From the day of operation until drain removal up to 90 days after the operation | Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded |
Countries
Italy
Outcome results
None listed