INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

Not Applicable

Completed

• Conditions: Colonic Cancer
• Interventions: Procedure: Intracorporeal anastomosis; Procedure: Extracorporeal anastomosis

• Registration Number: NCT03130166
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Study Start: 2018-05-01
• Primary Completion: 2020-12-29
• Study Completion: 2020-12-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracorporeal anastomosis	Intracorporeal anastomosis	Patients undergo robotic right colectomy with intracorporeal anastomosis.
Extracorporeal anastomosis	Extracorporeal anastomosis	Patients undergo robotic right colectomy with extracorporeal anastomosis.

Primary Outcome Measures

Name	Time	Method
Postoperative recovery	1 month	Questionnaire of Recovery 15 (QoR-15)

Secondary Outcome Measures

Name	Time	Method
Mortality	1 month
Postoperative pain	1 month
Whole blood gene expression profiling	1 month	Measuring changes in expression of ROS and immulogical genes due to surgery.
Length of hospital stay	1 month
Morbidity	1 month
Heart Rate Variability	2 days	Continuously ECG-monitoring intraoperatively and postoperatively
Ortostatic hypotension test	2 days
Postoperative opioid usage	1 month
Time to first bowel movement	1 month
Spirometry and PEF - test	2 days	Postoperative pulmonary function
Time fo first flatus	1 month
"Timed up and go"-test	2 days

Trial Locations

Locations (2)

Sealand University Hospital; 🇩🇰 Roskilde, Denmark

Herlev Hospital; 🇩🇰 Herlev, Copenhagen, Denmark