Gastrectomy With or Without Drainage (ADiGe)?

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Device: Avoid drain placement
* Device: Drain placement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Drain<br>Participants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered. | Device: Drain placement<br>* 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.<br>|
| Experimental: No Drain<br>Participants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered. | Device: Avoid drain placement<br>* In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 30 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality |  | 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. | 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 |  | 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 | From the day of operation until drain removal up to 90 days after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrectomy, Drain, Drainage