STOMACH trial: Surgical Technique, Open versus Minimally-invasive gastrectomy After CHemotherapy
Completed
- Conditions
- Gastric cancergastric carcinoma1001799010017991
- Registration Number
- NL-OMON47811
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Age equal to or above 18 years. Patients with primary adenocarcinoma of the stomach, with an indication for total gastrectomy. The tumour is considered surgically resectable (T1-2, N0-1, M0). Patients have received neoadjuvant chemotherapy (all therapeutic regimens are allowed). Patients are able to give informed consent.
Exclusion Criteria
Patients with previous or coexisting cancer. Patients who have had previous surgery of the stomach. Patients who are not deemed suitable for minimally-invasive surgical techniques by the operating surgeon, Patients with an ASA-score (American Society of Anaesthesiologists) of 4 or higher
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>As posed in the background information, it is imperative that a new surgical<br /><br>technique has similar results with regard to quality of oncological resection.<br /><br>The primary endpoint in the STOMACH trial is therefore quality of concological<br /><br>resection, as measured by radicality of surgery, the number of resected lymph<br /><br>nodes and the number of resected lymph nodes stations.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint in the STOMACH trial consist of postoperative complications<br /><br>according to the Clavien-Dindo classification, mortality, duration of hospital<br /><br>admission and 3-year survival. Along with quality of life as measured with<br /><br>Patient Related Outcome Measures (PROMs); the EQ-5D, and EORTC-QLQ30 and STO22<br /><br>questionnaires. Furthermore, a cost-efficiciency analysis will be conducted.</p><br>