1. Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial
- Author
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Kate Lykke Lambertsen, Andreas Kristian Pedersen, Mark Bremholm Ellebæk, Michael F. Nielsen, Pedja Cuk, Ismail Gögenur, Per Helligsø, and Christian Backer Mogensen
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Laparoscopic surgery ,medicine.medical_specialty ,RD1-811 ,Colorectal cancer ,medicine.medical_treatment ,Systemic inflammation ,law.invention ,Study Protocol ,Randomized controlled trial ,law ,Minimally invasive surgery ,Clinical endpoint ,medicine ,Humans ,Robot-assisted surgery ,Prospective Studies ,Randomized Controlled Trials as Topic ,Inflammatory surgical stress response ,business.industry ,Mortality rate ,Colonic Neoplasms/surgery ,General Medicine ,Robotics ,medicine.disease ,Systemic Inflammatory Response Syndrome ,Surgery ,Colon cancer ,Clinical trial ,Colonic Neoplasms ,Laparoscopy ,medicine.symptom ,business ,Complication - Abstract
Background Robot-assisted surgery is being increasingly adopted in treating colorectal cancer, and the transition from laparoscopic surgery to robot-assisted surgery is a trend. The evidence of the benefits of robot-assisted surgery is sparse. However, findings are associated with improved patient-related outcomes and overall morbidity rates compared to laparoscopic surgery. This induction is unclear, considering both surgical modalities are characterized as minimally invasive. This study aims to evaluate the systemic and peritoneal inflammatory stress response induced by robot-assisted surgery compared with laparoscopic surgery for elective colon cancer resections in a prospective, randomized controlled clinical trial. Methods This study is a single-centre randomized controlled superiority trial with 50 colon cancer participants. The primary endpoint is the level of systemic inflammatory response expressed as serum C-reactive protein (CRP) and interleukin 6 (IL-6) levels between postoperative days one and three. Secondary endpoints include (i) levels of systemic inflammation in serum expressed by a panel of inflammatory and pro-inflammatory cytokines measured during the first three postoperative days, (ii) postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index, (iii) intraoperative blood loss, (iv) conversion rate to open surgery, (v) length of surgery, (vi) operative time, (vii) the number of harvested lymph nodes, and (viii) length of hospital stay. The exploratory endpoints are (i) levels of peritoneal inflammatory response in peritoneal fluid expressed by inflammatory and pro-inflammatory cytokines between postoperative day one and three, (ii) patient-reported health-related quality of recovery-15 (QoR-15), (iii) 30 days mortality rate, (iv) heart rate variability and (v) gene transcript (mRNA) analysis. Discussion To our knowledge, this is the first clinical randomized controlled trial to clarify the inflammatory stress response induced by robot-assisted or laparoscopic surgery for colon cancer resections. Trial registration This trial is registered at Clinicaltrials.gov (Identifier: NCT04687384) on December, 29, 2020, Regional committee on health research ethics, Region of Southern Denmark (N75709) and Data Protection Agency, Hospital Sønderjylland, University Hospital of Southern Denmark (N20/46179).
- Published
- 2021
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