Immune protective anesthesia during endoscopic colon surgery to improve long-term survival
- Conditions
- immune systemnarcosis1002766510017991
- Registration Number
- NL-OMON46294
- Lead Sponsor
- Anesthesiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 366
Inclusion Criteria
- All patients approved by the anesthesiologist for elective endoscopic colon surgery for cancer.
- > 18 year with written informed consent
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 a any of the listed medications 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 use
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters:<br /><br><br /><br>immunological response 24hr-postoperative</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study parameters:<br /><br><br /><br>1. Is there a 48hr-postoperative difference in immunological response between<br /><br>conventional and immune protective anesthesia?<br /><br>2. Postoperative complications according to the Clavien Dindo classification<br /><br>3. Postoperative VAS (Visual Analogue Scale) score<br /><br>4. Hospital stay<br /><br>5. Anesthetic variables<br /><br><br /><br>Exploratory endpoint:<br /><br>1. Cancer free survival of colon surgery (follow up to 5 years<br /><br>postoperative)<br /><br><br /><br>During anesthesia: blood pressure, heart rate, respiratory rate, carbon dioxide<br /><br>concentration, saturation, and BIS values will be documented prior before<br /><br>anesthesia and every 10 minutes thereafter. Data will be collected<br /><br>prospectively.<br /><br><br /><br>Patient*s characteristics: age, BMI, smoking habits, medical history, ASA<br /><br>classification, tumor characteristics (histology, stage, TNM classification,<br /><br>localization). </p><br>