Pieter C van der Sluis1, Sylvia van der Horst1, Anne M May2, Carlo Schippers1, Lodewijk A A Brosens3, Hans C A Joore4, Christiaan C Kroese5, Nadia Haj Mohammad6, Stella Mook7, Frank P Vleggaar8, Inne H M Borel Rinkes1, Jelle P Ruurda1, Richard van Hillegersberg1. 1. Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands. 2. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. 3. Department of Pathology, University Medical Center Utrecht, Utrecht, The Netherlands. 4. Department of Intensive Care Medicine, University Medical Center Utrecht, Utrecht, The Netherlands. 5. Department of Anesthesiology, University Medical Center Utrecht, Utrecht, The Netherlands. 6. Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands. 7. Department of Radiotherapy, University Medical Center Utrecht, Utrecht, The Netherlands. 8. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
Abstract
BACKGROUND: The standard curative treatment for patients with esophageal cancer is perioperative chemotherapy or preoperative chemoradiotherapy followed by open transthoracic esophagectomy (OTE). Robot-assisted minimally invasive thoracolaparoscopic esophagectomy (RAMIE) may reduce complications. METHODS: A single-center randomized controlled trial was conducted, assigning 112 patients with resectable intrathoracic esophageal cancer to either RAMIE or OTE. The primary endpoint was the occurrence of overall surgery-related postoperative complications (modified Clavien-Dindo classification grade 2-5). RESULTS:Overall surgery-related postoperative complications occurred less frequently after RAMIE (59%) compared to OTE (80%) [risk ratio with RAMIE (RR) 0.74; 95% confidence interval (CI), 0.57-0.96; P = 0.02]. RAMIE resulted in less median blood loss (400 vs 568 mL, P <0.001), a lower percentage of pulmonary complications (RR 0.54; 95% CI, 0.34-0.85; P = 0.005) and cardiac complications (RR 0.47; 95% CI, 0.27-0.83; P = 0.006) and lower mean postoperative pain (visual analog scale, 1.86 vs 2.62; P < 0.001) compared to OTE. Functional recovery at postoperative day 14 was better in the RAMIE group [RR 1.48 (95% CI, 1.03-2.13; P = 0.038)] with better quality of life score at discharge [mean difference quality of life score 13.4 (2.0-24.7, p = 0.02)] and 6 weeks postdischarge [mean difference 11.1 quality of life score (1.0-21.1; P = 0.03)]. Short- and long-term oncological outcomes were comparable at a medium follow-up of 40 months. CONCLUSIONS: RAMIE resulted in a lower percentage of overall surgery-related and cardiopulmonary complications with lower postoperative pain, better short-term quality of life, and a better short-term postoperative functional recovery compared to OTE. Oncological outcomes were comparable and in concordance with the highest standards nowadays.
RCT Entities:
BACKGROUND: The standard curative treatment for patients with esophageal cancer is perioperative chemotherapy or preoperative chemoradiotherapy followed by open transthoracic esophagectomy (OTE). Robot-assisted minimally invasive thoracolaparoscopic esophagectomy (RAMIE) may reduce complications. METHODS: A single-center randomized controlled trial was conducted, assigning 112 patients with resectable intrathoracic esophageal cancer to either RAMIE or OTE. The primary endpoint was the occurrence of overall surgery-related postoperative complications (modified Clavien-Dindo classification grade 2-5). RESULTS: Overall surgery-related postoperative complications occurred less frequently after RAMIE (59%) compared to OTE (80%) [risk ratio with RAMIE (RR) 0.74; 95% confidence interval (CI), 0.57-0.96; P = 0.02]. RAMIE resulted in less median blood loss (400 vs 568 mL, P <0.001), a lower percentage of pulmonary complications (RR 0.54; 95% CI, 0.34-0.85; P = 0.005) and cardiac complications (RR 0.47; 95% CI, 0.27-0.83; P = 0.006) and lower mean postoperative pain (visual analog scale, 1.86 vs 2.62; P < 0.001) compared to OTE. Functional recovery at postoperative day 14 was better in the RAMIE group [RR 1.48 (95% CI, 1.03-2.13; P = 0.038)] with better quality of life score at discharge [mean difference quality of life score 13.4 (2.0-24.7, p = 0.02)] and 6 weeks postdischarge [mean difference 11.1 quality of life score (1.0-21.1; P = 0.03)]. Short- and long-term oncological outcomes were comparable at a medium follow-up of 40 months. CONCLUSIONS:RAMIE resulted in a lower percentage of overall surgery-related and cardiopulmonary complications with lower postoperative pain, better short-term quality of life, and a better short-term postoperative functional recovery compared to OTE. Oncological outcomes were comparable and in concordance with the highest standards nowadays.
Authors: Jan-Hendrik Egberts; M Biebl; D R Perez; S T Mees; P P Grimminger; B P Müller-Stich; H Stein; H Fuchs; C J Bruns; T Hackert; H Lang; J Pratschke; J Izbicki; J Weitz; T Becker Journal: J Gastrointest Surg Date: 2019-04-01 Impact factor: 3.452
Authors: Gijsbert I van Boxel; B Feike Kingma; Frank J Voskens; Jelle P Ruurda; Richard van Hillegersberg Journal: J Thorac Dis Date: 2020-02 Impact factor: 2.895
Authors: S van der Horst; C Voli; I A Polanco; R van Hillegersberg; J P Ruurda; B Park; D Molena Journal: Dis Esophagus Date: 2020-11-26 Impact factor: 3.429
Authors: Pieter Christiaan van der Sluis; Peter Philipp Grimminger; Richard van Hillegersberg; Jelle Piet-Hein Ruurda Journal: J Thorac Dis Date: 2019-09 Impact factor: 2.895