Peritoneal Cavity Conditioning During Open Surgery Decreases Postoperative Pain and Inflammation and Decreases Time to Restore Transit
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- KU Leuven
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Primary endpoint : decreased pain on day 1 and 2 after surgery
Study Overview
Brief Summary
Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit faster.
Detailed Description
Aim of the Trial :
RCT demonstrating that peritoneal cavity conditioning during open surgery will result in a less postoperative inflammation, less postoperative pain, and shorter time to flatus and transit.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary endpoint : decreased pain on day 1 and 2 after surgery
Time Frame: 0 to 7 days
Postoperative pain : will be assessed by visual analog scales (cfr Trial by Verguts \& Koninckx, addendum I) assessed pain on day 1, 2 and 3 after surgery. Pain medication will be free, but preferentially ibuprofen will be used in order to permit easier comparison of pain killer intake.
Secondary Outcomes
- decrease in CRP and inflammatory parameters on day 1 and 2 or longer(day 1-4)
- lower peritoneal fluid volume on day 2(day 2 after surgery)
- Shorter time to resumption of transit: time to first flatus and time to first stool(day1 to 5)