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INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03130166
Acronym
INEXA
Enrollment
100
Registered
2017-04-26
Start date
2018-05-01
Completion date
2020-12-29
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Cancer

Keywords

Postoperative pain, Postoperative recovery, Intracorporeal anastomosis, Robotic right colectomy

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.

Interventions

Use of intracorporeal anastomosis technique

Use of the conventional extracorporeal anastomosis technique

Sponsors

Herlev and Gentofte Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative recovery1 monthQuestionnaire of Recovery 15 (QoR-15)

Secondary

MeasureTime frameDescription
Time to first bowel movement1 month
Length of hospital stay1 month
Morbidity1 month
Mortality1 month
Postoperative pain1 month
Time fo first flatus1 month
Timed up and go-test2 days
Ortostatic hypotension test2 days
Spirometry and PEF - test2 daysPostoperative pulmonary function
Postoperative opioid usage1 month
Whole blood gene expression profiling1 monthMeasuring changes in expression of ROS and immulogical genes due to surgery.
Heart Rate Variability2 daysContinuously ECG-monitoring intraoperatively and postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026