Trial design, study registration, and ethics
THORACIC
The title of this clinical trial is “Drainless Robot-assisted Minimally Invasive Oesophagectomy” (RESPECT Trial). The study is designed as a randomized controlled multicentric, two-arm parallel-group superiority surgical trial with an interventional group (A: robot-assisted minimally invasive oesophagectomy with early removal of the chest drain) and a control group (B: robot-assisted minimally invasive oesophagectomy with chest drains). The study is coordinated by the leading Study Center of the Department of Visceral, Thoracic and Vascular Surgery, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Germany.Participating centres at the trial commencement are the two certified university centres: the Department of Visceral, Thoracic and Vascular Surgery, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Germany, and the Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany. Additional centres can be evaluated for participation if equivalent standards for the operation (RAMIE procedure with equal technique) and trial management can be guaranteed at these sites. The trial was registered in advance at ClinicalTrials.gov (