INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonic Cancer

Intervention / Treatment
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* Procedure: Intracorporeal anastomosis
* Procedure: Extracorporeal anastomosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracorporeal anastomosis<br>Patients undergo robotic right colectomy with intracorporeal anastomosis. | Procedure: Intracorporeal anastomosis<br>* Use of intracorporeal anastomosis technique<br>|
| Active Comparator: Extracorporeal anastomosis<br>Patients undergo robotic right colectomy with extracorporeal anastomosis. | Procedure: Extracorporeal anastomosis<br>* Use of the conventional extracorporeal anastomosis technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery | Questionnaire of Recovery 15 (QoR-15) | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Postoperative recovery, Intracorporeal anastomosis, Robotic right colectomy