Gastrectomy With or Without Drainage (ADiGe)?

Not Applicable

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT04227951
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-17
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Primary Completion: 2023-01-28
• Study Completion: 2023-03-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Overall mortality	90 days after the operation
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
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.

Trial Locations

Locations (11)

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

ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva; 🇮🇹 Milano, Italy

Ospedale San Raffaele - Chirurgia Gastroenterologica -; 🇮🇹 Milan, Italy

Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza; 🇮🇹 Modena, Italy

Ospedale Federico II di Napoli- Chirurgia Generale; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale; 🇮🇹 Parma, Italy

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