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INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy (INEXA)

Primary Purpose

Colonic Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intracorporeal anastomosis
Extracorporeal anastomosis
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Cancer focused on measuring Postoperative pain, Postoperative recovery, Intracorporeal anastomosis, Robotic right colectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Herlev Hospital
  • Sealand University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intracorporeal anastomosis

Extracorporeal anastomosis

Arm Description

Patients undergo robotic right colectomy with intracorporeal anastomosis.

Patients undergo robotic right colectomy with extracorporeal anastomosis.

Outcomes

Primary Outcome Measures

Postoperative recovery
Questionnaire of Recovery 15 (QoR-15)

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2017
Last Updated
January 3, 2021
Sponsor
Herlev and Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03130166
Brief Title
INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy
Acronym
INEXA
Official Title
Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 29, 2020 (Actual)
Study Completion Date
December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer
Keywords
Postoperative pain, Postoperative recovery, Intracorporeal anastomosis, Robotic right colectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracorporeal anastomosis
Arm Type
Experimental
Arm Description
Patients undergo robotic right colectomy with intracorporeal anastomosis.
Arm Title
Extracorporeal anastomosis
Arm Type
Active Comparator
Arm Description
Patients undergo robotic right colectomy with extracorporeal anastomosis.
Intervention Type
Procedure
Intervention Name(s)
Intracorporeal anastomosis
Intervention Description
Use of intracorporeal anastomosis technique
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal anastomosis
Intervention Description
Use of the conventional extracorporeal anastomosis technique
Primary Outcome Measure Information:
Title
Postoperative recovery
Description
Questionnaire of Recovery 15 (QoR-15)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Time fo first flatus
Time Frame
1 month
Title
Time to first bowel movement
Time Frame
1 month
Title
Length of hospital stay
Time Frame
1 month
Title
Morbidity
Time Frame
1 month
Title
Mortality
Time Frame
1 month
Title
Postoperative pain
Time Frame
1 month
Title
Heart Rate Variability
Description
Continuously ECG-monitoring intraoperatively and postoperatively
Time Frame
2 days
Title
"Timed up and go"-test
Time Frame
2 days
Title
Ortostatic hypotension test
Time Frame
2 days
Title
Spirometry and PEF - test
Description
Postoperative pulmonary function
Time Frame
2 days
Title
Postoperative opioid usage
Time Frame
1 month
Title
Whole blood gene expression profiling
Description
Measuring changes in expression of ROS and immulogical genes due to surgery.
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
State/Province
Copenhagen
Country
Denmark
Facility Name
Sealand University Hospital
City
Roskilde
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36171282
Citation
Dohrn N, Oppermann C, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. The effect of intracorporeal versus extracorporeal anastomosis in robotic right colectomy on perianastomotic perfusion: a substudy to a multicenter RCT. Langenbecks Arch Surg. 2022 Dec;407(8):3577-3586. doi: 10.1007/s00423-022-02693-4. Epub 2022 Sep 28.
Results Reference
derived
PubMed Identifier
35129520
Citation
Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13.
Results Reference
derived
PubMed Identifier
33913415
Citation
Dohrn N, Klein MF, Gogenur I. Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial. Dan Med J. 2021 Apr 20;68(5):A09200710.
Results Reference
derived

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INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

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