Clinical trial NCT03130166: INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy
Official title: Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Cancer
Keywords: Postoperative pain
Postoperative recovery
Intracorporeal anastomosis
Robotic right colectomy
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.

The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.


Eligibility criteria: Inclusion Criteria:

All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.

Primary outcomes:
measure: Postoperative recovery
timeFrame: 1 month
Secondary outcomes:
measure: Time fo first flatus
timeFrame: 1 month
measure: Time to first bowel movement
timeFrame: 1 month
measure: Length of hospital stay
timeFrame: 1 month
measure: Morbidity
timeFrame: 1 month
measure: Mortality
timeFrame: 1 month
measure: Postoperative pain
timeFrame: 1 month
measure: Heart Rate Variability
timeFrame: 2 days
measure: "Timed up and go"-test
timeFrame: 2 days
measure: Ortostatic hypotension test
timeFrame: 2 days
measure: Spirometry and PEF - test
timeFrame: 2 days
measure: Postoperative opioid usage
timeFrame: 1 month
measure: Whole blood gene expression profiling
timeFrame: 1 month
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Copenhagen
city: Roskilde
country: Denmark
facility: Sealand University Hospital
Study officials:
References:
citation: Dohrn N, Oppermann C, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. The effect of intracorporeal versus extracorporeal anastomosis in robotic right colectomy on perianastomotic perfusion: a substudy to a multicenter RCT. Langenbecks Arch Surg. 2022 Dec;407(8):3577-3586. doi: 10.1007/s00423-022-02693-4. Epub 2022 Sep 28.
citation: Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13.
citation: Dohrn N, Klein MF, Gogenur I. Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial. Dan Med J. 2021 Apr 20;68(5):A09200710.