‘Immune protective anesthesia during endoscopic colon surgery to improve long-term survival’

Phase 1

Conditions: Therapeutic area: Diseases [C] - Cancer [C04]
We will include patients with colon cancer receiving endoscopic resection of tumor

Registration Number: EUCTR2017-000867-34-NL

Lead Sponsor: MCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

- All patients approved by the anesthesiologist for elective endoscopic colon surgery for cancer.
- > 18 year with written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

- neoadjuvant chemo and/or radiotherapy
- Perioperatieve conversion to an open surgical approach
- Insufficient pain relief in the intervention group (Visual Analogue Scale (VAS) = 4)
- Absolute contra-indications for the use of any of the listed medications or procedures (epidural) in the intervention group
- Synchronous metastasis (stage IV/ M1 patients)
- Patients who are mentally disabled or incapable to give informed consent
- Patients on chronic opioid therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the immunological response between two different anesthesia strategies ;Secondary Objective: 1. Cancer free survival (follow up to 5 years postoperative) <br>2. Minor and major postoperative complications <br>3. Postoperative VAS (Visual Analogue Scale) score<br>4. Hospital stay <br>5. Anesthetic variables <br>;Primary end point(s): Immunological markers;Timepoint(s) of evaluation of this end point: After inclusion of last patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Cancer free survival (follow up to 5 years postoperative) <br>2. Minor and major postoperative complications <br>3. Postoperative VAS (Visual Analogue Scale) score<br>4. Hospital stay <br>5. Anesthetic variables such as:blood pressure, heart rate, respiratory rate, carbon dioxide concentration, saturation, and BIS values will be documented prior before anesthesia and every 10 minutes thereafter. Data will be collected prospectively<br>;Timepoint(s) of evaluation of this end point: secondary endpoint 1 , 5 years after inclusion of last patient.<br>Other secondary markers after inclusion of last patient.