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

被引:2
|
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
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.
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页数:7
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