Abstract
Background
The purpose of this randomized trial is to evaluate the early removal of postoperative drains after robot-assisted minimally invasive oesophagectomy (RAMIE). Evidence is lacking about feasibility, associated pain, recovery, and morbidity.
Methods/design
This is a randomized controlled multicentric trial involving 72 patients undergoing RAMIE. Patients will be allocated into two groups. The “intervention” group consists of 36 patients. In this group, abdominal and chest drains are removed 3 h after the end of surgery in the absence of contraindications. The control group consists of 36 patients with conventional chest drain management. These drains are removed during the further postoperative course according to a standard algorithm. The primary objective is to investigate whether postoperative pain measured by NRS on the second postoperative day can be significantly reduced in the intervention group. Secondary endpoints are the intensity of pain during the first week, analgesic use, number of postoperative chest X-ray and CT scans, interventions, postoperative mobilization (steps per day as measured with an activity tracker), postoperative morbidity and mortality.
Discussion
Until now, there have been no trials investigating different intraoperative chest drain strategies in patients undergoing RAMIE for oesophageal cancer with regard to perioperative complications until discharge. Minimally invasive approaches combined with enhanced recovery after surgery (ERAS) protocols lower morbidity but still include the insertion of chest drains. Reduction and early removal have been proposed after pulmonary surgery but not after RAMIE. The study concept is based on our own experience and the promising current results of the RAMIE procedure. Therefore, the presented randomized controlled trial will provide statistical evidence of the effectiveness and feasibility of the “drainless” RAMIE.
Trial registration
ClinicalTrials.gov NCT05553795. Registered on 23 September 2022.
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Details
1 University Hospital and Faculty of Medicine Carl Gustav CarusTechnische Universität Dresden, Department of Visceral, Thoracic and Vascular Surgery, Dresden, Germany (GRID:grid.412282.f) (ISNI:0000 0001 1091 2917); St. Elisabethen-Klinikum Ravensburg, Academic Teaching Hospital of the University of Ulm, Current Address: Department of General, Visceral and Thoracic Surgery, Ulm, Germany (GRID:grid.6582.9) (ISNI:0000 0004 1936 9748); National Center for Tumour Diseases (NCT/UCC), Dresden, Germany (GRID:grid.6582.9)
2 University Hospital and Faculty of Medicine Carl Gustav CarusTechnische Universität Dresden, Department of Visceral, Thoracic and Vascular Surgery, Dresden, Germany (GRID:grid.412282.f) (ISNI:0000 0001 1091 2917); National Center for Tumour Diseases (NCT/UCC), Dresden, Germany (GRID:grid.412282.f); German Cancer Research Center (DKFZ), Heidelberg, Germany (GRID:grid.7497.d) (ISNI:0000 0004 0492 0584); Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257); Helmholtz-Zentrum Dresden - Rossendorf (HZDR), Dresden, Germany (GRID:grid.40602.30) (ISNI:0000 0001 2158 0612)
3 University Hospital and Faculty of Medicine Carl Gustav CarusTechnische Universität Dresden, Department of Visceral, Thoracic and Vascular Surgery, Dresden, Germany (GRID:grid.412282.f) (ISNI:0000 0001 1091 2917); National Center for Tumour Diseases (NCT/UCC), Dresden, Germany (GRID:grid.412282.f); German Cancer Research Center (DKFZ), Heidelberg, Germany (GRID:grid.7497.d) (ISNI:0000 0004 0492 0584); Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257); National Center for Tumour Diseases (NCT), Core Unit for Data Management and Analytics, Dresden, Germany (GRID:grid.4488.0)
4 University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Department of Anaesthesiology and Critical Care Medicine, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257)
5 Heidelberg University Hospital, Department of General, Visceral and Transplantation Surgery, Heidelberg, Germany (GRID:grid.5253.1) (ISNI:0000 0001 0328 4908)
6 Heidelberg University Hospital, Department of Anaesthesiology, Heidelberg, Germany (GRID:grid.5253.1) (ISNI:0000 0001 0328 4908)
7 National Center for Tumour Diseases (NCT/UCC), Dresden, Germany (GRID:grid.4488.0); German Cancer Research Center (DKFZ), Heidelberg, Germany (GRID:grid.7497.d) (ISNI:0000 0004 0492 0584); Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257); National Center for Tumour Diseases (NCT), Core Unit for Data Management and Analytics, Dresden, Germany (GRID:grid.4488.0)
8 Technische Universität Dresden, Coordination Centre for Clinical Trials, Faculty of Medicine Carl Gustav Carus, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257)
9 National Center for Tumour Diseases (NCT/UCC), Dresden, Germany (GRID:grid.4488.0); German Cancer Research Center (DKFZ), Heidelberg, Germany (GRID:grid.7497.d) (ISNI:0000 0004 0492 0584); Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257); Heidelberg University Hospital, Department of General, Visceral and Transplantation Surgery, Heidelberg, Germany (GRID:grid.5253.1) (ISNI:0000 0001 0328 4908); University Hospital Hamburg-Eppendorf, Department of General, Visceral and Thoracic Surgery, Hamburg, Germany (GRID:grid.13648.38) (ISNI:0000 0001 2180 3484)