Gastrectomy With or Without Drainage (ADiGe)? (ADiGe)

November 27, 2023 updated by: Azienda Ospedaliera Universitaria Integrata Verona

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy
        • Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica
      • Bologna, Italy
        • Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale
      • Cremona, Italy
        • Ospedale di Cremona
      • Milan, Italy
        • Ospedale San Raffaele - Chirurgia Gastroenterologica -
      • Milano, Italy
        • ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva
      • Modena, Italy
        • Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza
      • Napoli, Italy
        • Ospedale Federico II di Napoli- Chirurgia Generale
      • Parma, Italy
        • Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale
      • Verona, Italy, 37124
        • Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
    • Forlì-Cesena
      • Forlì, Forlì-Cesena, Italy
        • Ospedale Morgagni di Forlì - Chirurgia generale
    • Torino
      • Orbassano, Torino, Italy
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Drain
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
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.
Experimental: No Drain
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
In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

  • Principal Investigator: Giovanni de Manzoni, Prof, Universita Degli Studi Di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Actual)

January 28, 2023

Study Completion (Actual)

March 29, 2023

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2245CESC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in abdominal surgery. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact jacopo.weindelmayer@aovr.veneto.it

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Drain placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe