INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy (INEXA)
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|ClinicalTrials.gov Identifier: NCT03130166|
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : August 7, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Postoperative recovery [ Time Frame: 1 month ]Questionnaire of Recovery 15 (QoR-15)
- 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.
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
|Contact: Niclas Dohrn, MD||0045 email@example.com|
|Contact: Mads Klein, MD, Ph.D|
|Herlev, Copenhagen, Denmark|
|Contact: Niclas Dohrn, MD|
|Sealand University Hospital||Recruiting|
|Contact: Mads Klein, MD, Phd|