Surgical stress response in robot-assisted versus laparoscopic surgery for colon cancer (SIRIRALS): randomized clinical trial

被引:10
作者
Cuk, Pedja [1 ,2 ,3 ]
Tiskus, Mindaugas [1 ]
Moller, Soeren [3 ,4 ]
Lambertsen, Kate Lykke [5 ,6 ,7 ]
Backer Mogensen, Christian [2 ,8 ]
Festersen Nielsen, Michael [1 ,2 ]
Helligso, Per [1 ]
Gogenur, Ismail [9 ]
Bremholm Ellebaek, Mark [3 ,4 ,10 ]
机构
[1] Hosp Southern Jutland, Dept Surg, Aabenraa, Denmark
[2] Univ Southern Denmark, Inst Reg Hlth Res, Odense, Denmark
[3] Odense Univ Hosp, Open Patient Data Explorat Network, Odense, Denmark
[4] Univ Southern Denmark, Dept Clin Res, Odense, Denmark
[5] Univ Southern Denmark, Inst Mol Med, Dept Neurobiol Res, Odense, Denmark
[6] Odense Univ Hosp, Dept Neurol, Odense, Denmark
[7] Univ Southern Denmark, Dept Clin Res, BRIDGE, Odense, Denmark
[8] Univ Hosp Southern Denmark, Hosp Sonderjylland, Dept Emergency Med, Aabenraa, Denmark
[9] Zealand Univ Hosp, Ctr Surg Sci, Surg Dept, Koege, Denmark
[10] Odense Univ Hosp, Res Unit Surg, Odense, Denmark
来源
BJS-BRITISH JOURNAL OF SURGERY | 2024年 / 111卷 / 03期
关键词
IMPORTANT DIFFERENCE; QUALITY; CLASSIFICATION; SEVERITY; SURVIVAL; OUTCOMES; COHORT;
D O I
10.1093/bjs/znae049
中图分类号
R61 [外科手术学];
学科分类号
摘要
Background Evidence for the routine use of robotic technology and its impact on short-term outcomes in colon cancer surgery is lacking. The aim of this study was to compare the surgically induced systemic stress response and clinical and patient-reported outcomes for patients undergoing robot-assisted or laparoscopic colon cancer surgery.Methods In this double-blinded superiority RCT completed between August 2021 and March 2023, patients with stage 1-3 colon cancer were randomized in a 1 : 1 ratio to undergo either robot-assisted or laparoscopic colon cancer surgery. The primary outcome was changes in the systemic stress response, characterized by C-reactive protein expression in the first three postoperative days. Secondary outcomes were intraoperative and postoperative complications and patient-reported outcomes. The latter included quality of recovery-15 and pain intensity using a visual analogue scale.Results In total, 128 patients were screened for potential inclusion in this study; 50 patients (25 in the robot-assisted group and 25 in the laparoscopic group) were included in the final follow-up and analysis. The postoperative C-reactive protein response was higher on the first postoperative day in the laparoscopic group (mean difference = 19.88 mg/l, 95% c.i. 3.89-35.86; P = 0.045). No statistically significant differences were noted for C-reactive protein expression on the second and third postoperative days.Conclusion Adopting robot-assisted surgery for stage 1-3 colon cancer is associated with a reduction in the surgical stress response.Registration number NCT04687384 (http://www.clinicaltrials.gov). The aim of this RCT was to investigate the perioperatively induced systemic stress response and clinical and patient-reported outcomes for patients undergoing robot-assisted or laparoscopic colon cancer surgery. Adopting RCS resulted in a lower stress response. However, it did not cause an improvement in recovery rates or patient-reported outcomes.
引用
收藏
页数:7
相关论文
共 35 条
[1]   Inflammatory and Immune Responses to Surgery and Their Clinical Impact [J].
Alazawi, William ;
Pirmadjid, Negar ;
Lahiri, Rajiv ;
Bhattacharya, Satyajit .
ANNALS OF SURGERY, 2016, 264 (01) :73-80
[2]  
Bonjer HJ, 2009, LANCET ONCOL, V10, P44, DOI 10.1016/S1470-2045(08)70310-3
[3]   Laparoscopic surgery versus open surgery for colon cancer:: short-term outcomes of a randomised trial [J].
Bonjer, HJ ;
Haglind, E ;
Jeekel, I ;
Kazemier, G ;
Páhlman, L ;
Hop, WCJ ;
Veldkamp, R ;
Kuhry, E ;
Haglind, E ;
Pahlman, L ;
Cuesta, MA ;
Msika, S ;
Morino, M ;
Lacy, A ;
Jeekel, I .
LANCET ONCOLOGY, 2005, 6 (07) :477-484
[4]   Short-term outcomes in robot-assisted compared to laparoscopic colon cancer resections: a systematic review and meta-analysis [J].
Cuk, Pedja ;
Kjaer, Mie Dilling ;
Mogensen, Christian Backer ;
Nielsen, Michael Festersen ;
Pedersen, Andreas Kristian ;
Ellebaek, Mark Bremholm .
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2022, 36 (01) :32-46
[5]   Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial [J].
Cuk, Pedja ;
Pedersen, Andreas Kristian ;
Lambertsen, Kate Lykke ;
Mogensen, Christian Backer ;
Nielsen, Michael Festersen ;
Helligso, Per ;
Gogenur, Ismail ;
Ellebaek, Mark Bremholm .
BMC SURGERY, 2021, 21 (01)
[6]   Improved perioperative outcomes and reduced inflammatory stress response in malignant robot-assisted colorectal resections: a retrospective cohort study of 298 patients [J].
Cuk, Pedja ;
Simonsen, Randi Maria ;
Komljen, Mirjana ;
Nielsen, Michael Festersen ;
Helligso, Per ;
Pedersen, Andreas Kristian ;
Mogensen, Christian Backer ;
Ellebaek, Mark Bremholm .
WORLD JOURNAL OF SURGICAL ONCOLOGY, 2021, 19 (01)
[7]   Anaesthesia, analgesia, and the surgical stress response [J].
Cusack, B. ;
Buggy, D. J. .
BJA EDUCATION, 2020, 20 (09) :321-328
[8]  
Dindo D, 2004, ANN SURG, V240, P205, DOI [10.17116/hirurgia2018090162, 10.1097/01.sla.0000133083.54934.ae]
[9]   Addressing the global burden of trauma in major surgery [J].
Dobson, Geoffrey P. .
FRONTIERS IN SURGERY, 2015, 2
[10]   Bonferroni-Holm and permutation tests to compare health data: methodological and applicative issues [J].
Giacalone, Massimiliano ;
Agata, Zirilli ;
Cozzucoli, Paolo Carmelo ;
Alibrandi, Angela .
BMC MEDICAL RESEARCH METHODOLOGY, 2018, 18