ROBOT trial: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy vs. open transthoracic esophagectomy: A randomized controlled trial.
Completed
- Conditions
- Esophageal carcinomaSlokdarmcrinoom
- Registration Number
- NL-OMON28386
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
Inclusion Criteria
1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus;
2. Surgical resectable (T1-4a, N0-3, M0);
Exclusion Criteria
1. Carcinoma of the cervical esophagus;
2. Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification.
- Secondary Outcome Measures
Name Time Method Iindividual components of the primary endpoint (major and minor complications), (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, oncologic outcomes, cost-effectiveness and quality of life.