Table 1 World Health Organization Trial Registration Data Set
Data category | Information |
|---|---|
Primary registry and trial identifying number | |
Date of registration in primary registry | 13th March, 2020 |
Secondary identifying numbers | ROBOT2 trial, 2019–14,049 |
Source of material support | Intuitive Surgical Inc. |
Primary sponsor | Intuitive Surgical Inc. |
Contact for public queries | ET, PPG [email address] |
Contact for scientific queries | ET, PPG University Medical Center Mainz, Mainz, Germany |
Public title | RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial). |
Scientific title | Randomized controlled parallel-group, superiority trial comparing RAMIE to MIE with intrathoracic anastomosis (Ivor-Lewis) in patients with resectable intrathoracic esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. |
Countries of recruitment | Germany, The Netherlands, Switzerland |
Health condition(s) or problem(s) studied | Experimental: Robotic assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer |
Intervention(s) | Active comparator: Minimally invasive esophagectomy (MIE) for esophageal cancer |
Key inclusion and exclusion criteria | Ages eligible for study: 18–90 years of age Sexes eligible for study: both Accepts healthy volunteers: no Inclusion criteria: Histologically proven adenocarcinoma of the intrathoracic esophagus and gastroesophageal junction (including Siewert types I and II) Surgically resectable (T1-4a, N0–3, M0) European Clinical Oncology Group (ECOG) performance status 0,1 or 2 Written informed consent Exclusion criteria: Esophageal squamous cell carcinoma Carcinoma of the cervical esophagus Carcinoma of the esophageal junction (GEJ) with the main part of the tumor in the gastric cardia (Siewert type III) Prior thoracic surgery at the right hemithorax or thoracic trauma |
Study type | Interventional Allocation: randomized; Intervention model: parallel assignment; Masking: single (outcomes assessor); Masking description: anonymous cases Primary purpose: treatment |
Date of first enrolment | 18th January 2021 |
Target sample size | 218 |
Recruitment status | Recruiting |
Primary outcome(s) | Total number of dissected lymph nodes in the resection specimen according to the TIGER classification |
Key secondary outcomes | 1.Postoperative complications [Time Frame: Operation date till date of discharge until 52 weeks postoperatively] 2.Length of intensive care unit (ICU) and hospital stay [Time Frame: Operation date till date of discharge until 52 weeks postoperatively] 3.In hospital mortality (IHM) [Time Frame: Hospital admission period up to 90 days postoperatively] 30, 60 and 90 day mortality 4.Pathology results [Time Frame: Up to 2 weeks postoperatively] Radical resection (R0 and R1) 5.Survival [Time Frame: 5 years postoperatively] Overall and disease free survival (2,3 and 5 year) 6.Operation statistics [Time Frame: day of operation] Operating time (thoracic, abdominal and total), blood loss, intraoperative complications 7.Postoperative pain [Time Frame: Before operation (baseline), daily during admission in the first 14 days, postoperatively: 6 weeks, 6 months and yearly post-operatively up to 5 years] Postoperative pain scores on a visual analogue scale (VAS) 8.Cost analysis [Time Frame: date of operation until 1 year postoperatively] Cost analysis 9.Surgeons fatigue [Time Frame: Day of operation] Surgeons fatigue directly after Operation assessed by Psychomotor Vigilance tests (PVT) before and after esophagectomy 10.Quality of life after esophagectomy [Time Frame: Before operation (baseline), at discharge, postoperatively: 6 weeks, 6 months and yearly up to 5 years post-operatively] Quality of life assessed by questionnaire European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 11.Postoperative Recovery [Time Frame: 14 days postoperatively] Dutch discharge criteria (removal of thoracic tubes, no requirement of intravenous fluid resuscitation, tolerance for solid oral intake, the ability to mobilize independently and adequate pain control with oral analgesics) 12.Quality of life after esophagectomy [Time Frame: Before operation (baseline), at discharge, postoperatively: 6 weeks, 6 months and yearly up to 5 years post-operatively] Quality of life assessed by questionnaire European Organisation for Research and Treatment of Cancer (EORTC OES18) 13.Quality of life after esophagectomy [Time Frame: Before operation (baseline), at discharge, postoperatively: 6 weeks, 6 months and yearly up to 5 years post-operatively] Quality of life assessed by questionnaire Short Form (SF)-36 14.Quality of life after esophagectomy [Time Frame: Before operation (baseline), at discharge, postoperatively: 6 weeks, 6 months and yearly up to 5 years post-operatively] Quality of life assessed by questionnaire EuroQol (EQ)-5D |