INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

Overview

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.

Full Title of Study: “Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy – a Double-blinded Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2021

Interventions

  • Procedure: Intracorporeal anastomosis
    • Use of intracorporeal anastomosis technique
  • Procedure: Extracorporeal anastomosis
    • Use of the conventional extracorporeal anastomosis technique

Arms, Groups and Cohorts

  • Experimental: Intracorporeal anastomosis
    • Patients undergo robotic right colectomy with intracorporeal anastomosis.
  • Active Comparator: Extracorporeal anastomosis
    • Patients undergo robotic right colectomy with extracorporeal anastomosis.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative recovery
    • Time Frame: 1 month
    • Questionnaire of Recovery 15 (QoR-15)

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Herlev and Gentofte Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Niclas Dohrn, MD. – Herlev and Gentofte Hospital
  • Overall Contact(s)
    • Niclas Dohrn, MD, 0045 21289777, niclas.dohrn@gmail.com

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