MEGA Trial - Minimally invasivE versus open Gastrectomy.A multicenter randomized controlled trial.
- Conditions
- C16Malignant neoplasm of stomach
- Registration Number
- DRKS00025765
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Planned total gastrectomy after first diagnosis of gastric cancer
- Ability of patient to understand character and individual consequences of the clinical trial
- Written informed consent
- ECOG performance status > 2
- Planned extended gastrectomy or less than total gastrectomy (e.g. adenocarcinoma of esophagogastric junction (AEG) I and AEG II, distal gastric tumors of intestinal subtype)
- Previous gastric surgery or extensive adhesions seriously complicating MIG
- Other active oncologic disease or history of cancer limiting prognosis in comparison to the gastric cancer
- Emergency setting
- Language problems rendering patient unable to fill out patient reported outcome questionnaires
- Participation in another intervention-trial with interference of intervention and/or outcome of this trial
- Pregnancy
Exclusion criteria previously or during staging
laparoscopy:
- T4
- M1
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative morbidity measured with the Comprehensive Complication Index (CCI) until postoperative day (POD) 30
- Secondary Outcome Measures
Name Time Method