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Completed

NCT Number: NCT03130166

INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

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.

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Key information

Conditions

Colonic Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Herlev, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Intracorporeal anastomosis

Procedure

Use of intracorporeal anastomosis technique

Extracorporeal anastomosis

Procedure

Use of the conventional extracorporeal anastomosis technique

Primary outcomes

  1. Postoperative recovery

    Time frame: 1 month

    Questionnaire of Recovery 15 (QoR-15)

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

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

Acronym: INEXA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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