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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130166
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Niclas Dohrn, 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.


Condition or disease Intervention/treatment Phase
Colonic Cancer Procedure: Intracorporeal anastomosis Procedure: Extracorporeal anastomosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Postoperative recovery [ Time Frame: 1 month ]
    Questionnaire of Recovery 15 (QoR-15)


Secondary Outcome Measures :
  1. Time fo first flatus [ Time Frame: 1 month ]
  2. Time to first bowel movement [ Time Frame: 1 month ]
  3. Length of hospital stay [ Time Frame: 1 month ]
  4. Morbidity [ Time Frame: 1 month ]
  5. Mortality [ Time Frame: 1 month ]
  6. Postoperative pain [ Time Frame: 1 month ]
  7. Heart Rate Variability [ Time Frame: 2 days ]
    Continuously ECG-monitoring intraoperatively and postoperatively

  8. "Timed up and go"-test [ Time Frame: 2 days ]
  9. Ortostatic hypotension test [ Time Frame: 2 days ]
  10. Spirometry and PEF - test [ Time Frame: 2 days ]
    Postoperative pulmonary function

  11. Postoperative opioid usage [ Time Frame: 1 month ]
  12. Whole blood gene expression profiling [ Time Frame: 1 month ]
    Measuring changes in expression of ROS and immulogical genes due to surgery.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130166


Contacts
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Contact: Niclas Dohrn, MD 0045 21289777 niclas.dohrn@gmail.com
Contact: Mads Klein, MD, Ph.D

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Copenhagen, Denmark
Contact: Niclas Dohrn, MD         
Sealand University Hospital Recruiting
Roskilde, Denmark
Contact: Mads Klein, MD, Phd         
Sponsors and Collaborators
Herlev and Gentofte Hospital
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Responsible Party: Niclas Dohrn, MD., Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03130166    
Other Study ID Numbers: RCT0001
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niclas Dohrn, Herlev and Gentofte Hospital:
Postoperative pain
Postoperative recovery
Intracorporeal anastomosis
Robotic right colectomy
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases