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INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy (INEXA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130166
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Niclas Dohrn, Herlev and Gentofte Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2017
First Posted Date  ICMJE April 26, 2017
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date December 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
Postoperative recovery [ Time Frame: 1 month ]
Questionnaire of Recovery 15 (QoR-15)
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Postoperative pain [ Time Frame: 1 month ]
  • Postoperative recovery [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy
Official Title  ICMJE Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colonic Cancer
Intervention  ICMJE
  • Procedure: Intracorporeal anastomosis
    Use of intracorporeal anastomosis technique
  • Procedure: Extracorporeal anastomosis
    Use of the conventional extracorporeal anastomosis technique
Study Arms  ICMJE
  • Experimental: Intracorporeal anastomosis
    Patients undergo robotic right colectomy with intracorporeal anastomosis.
    Intervention: Procedure: Intracorporeal anastomosis
  • Active Comparator: Extracorporeal anastomosis
    Patients undergo robotic right colectomy with extracorporeal anastomosis.
    Intervention: Procedure: Extracorporeal anastomosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 29, 2020
Actual Primary Completion Date December 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03130166
Other Study ID Numbers  ICMJE RCT0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Niclas Dohrn, Herlev and Gentofte Hospital
Study Sponsor  ICMJE Herlev and Gentofte Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Herlev and Gentofte Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP