INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy (INEXA)

January 3, 2021 updated by: Niclas Dohrn, Herlev and Gentofte Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark
        • Sealand University Hospital
    • Copenhagen
      • Herlev, Copenhagen, Denmark
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intracorporeal anastomosis
Patients undergo robotic right colectomy with intracorporeal anastomosis.
Procedure: Intracorporeal anastomosis
Use of intracorporeal anastomosis technique
ACTIVE_COMPARATOR: Extracorporeal anastomosis
Patients undergo robotic right colectomy with extracorporeal anastomosis.
Procedure: Extracorporeal anastomosis
Use of the conventional extracorporeal anastomosis technique

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

December 29, 2020

Study Completion (ACTUAL)

December 29, 2020

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (ACTUAL)

April 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 3, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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