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NCT Number: NCT04227951

Gastrectomy With or Without Drainage (ADiGe)?

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Morgagni di Forlì - Chirurgia generale, Forlì, Forlì-Cesena, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Avoid drain placement

Device

In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.

Drain placement

Device

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.

Primary outcomes

  1. 30 day reoperation AND/OR additional drain placement

    Time frame: 30 days after the operation

    Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)

Secondary outcomes

  1. Overall mortality

    Time frame: 90 days after the operation

  2. Overall morbidity

    Time frame: 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.

  3. 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.

  4. Drain related complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: ADiGe

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2020
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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