Spots Global Cancer Trial Database for Gastrectomy With or Without Drainage (ADiGe)?
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Trial Identification
Brief Title: Gastrectomy With or Without Drainage (ADiGe)?
Official Title: A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)
Study ID: NCT04227951
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco, Verona, , Italy
Contact Details
Name: Giovanni de Manzoni, Prof
Affiliation: Università degli studi di Verona
Role: PRINCIPAL_INVESTIGATOR
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