C16
Conditions
Interventions
Group 1: Minimally invasive gastrectomy
Group 2: Open gastrectomy
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative morbidity measured with the Comprehensive Complication Index (CCI) until postoperative day (POD) 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-term clinical endpoints: - Postoperative morbidity measured with the CCI until POD 90 - Major complications (Clavien-Dindo = 3) until POD 90 - Conversion rate - Operation time calculated from incision to skin closure - Blood loss as estimated by the surgeons - Length of stay in the ICU - Length of hospital stay - Pain and postoperative analgesic required (visual analog scale of pain and given medication) - Laboratory parameters (CRP, leucocytes) - Mobilization of the patient as time to achieved first mobilization to the edge of the bed as well as to the first postoperative walk - Quality of the patient's recovery score (QoR-15) - Quality of life (QoL) as "patient reported outcome" (PRO) using established questionnaires (EUROQOL EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-STO22, ADLs) - Adherence to a fast-track gastrectomy SOP - Objective evaluation of anastomoses - First bowl function and mobilization - Wound healing deficits - Vegetative function - Necessity of interventions due to complications Oncologic short-term endpoints: - Number of lymph nodes removed - Number of tumor-positive lymph nodes - Number of R0 resections - Development of tumor markers (Carbohydrate antigen (CA) 125, CA 19-9, CA 72-4, Carcinoembryonic antigen (CEA)) - Tumor histopathology Long-term clinical endpoints (5-year FU): - Changes of body weight - QoL as “patient reported outcome” (PRO) using established questionnaires (EUROQOL EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-STO22, ADLs, BIS) - Incidence of incisional hernias - Incidence of reoperations - Incidence of stenosis of anastomoses requiring interventional treatment - Cosmetic results and scar satisfaction Oncologic long-term endpoints (5-year FU): - Oncological treatment (adjuvant and consecutive therapy) - Disease-free survival; recurrence free survival - Local recurrence - Relapse-free survival - Progression-free survi | — |
Countries
Germany, Switzerland
Contacts
Public ContactFelix Nickel
Universitätsklinikum Hamburg-Eppendorf (UKE)
Outcome results
None listed