INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

Colonic Cancer Clinical Trial

— INEXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130166
• Other study ID #: RCT0001
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 29, 2020

Study information

• Verified date: January 2021
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev	Copenhagen
Denmark	Sealand University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative recovery	Questionnaire of Recovery 15 (QoR-15)	1 month
Secondary	Time fo first flatus		1 month
Secondary	Time to first bowel movement		1 month
Secondary	Length of hospital stay		1 month
Secondary	Morbidity		1 month
Secondary	Mortality		1 month
Secondary	Postoperative pain		1 month
Secondary	Heart Rate Variability	Continuously ECG-monitoring intraoperatively and postoperatively	2 days
Secondary	"Timed up and go"-test		2 days
Secondary	Ortostatic hypotension test		2 days
Secondary	Spirometry and PEF - test	Postoperative pulmonary function	2 days
Secondary	Postoperative opioid usage		1 month
Secondary	Whole blood gene expression profiling	Measuring changes in expression of ROS and immulogical genes due to surgery.	1 month