Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | open surgery with exposure of the surgical wound to the air. | ||
| Full peritoneal conditioning | Full peritoneum cavity conditioning will be performed as follows. A continuous flow of less than 0.5 l/min of gas will be instilled in the lowest part of the operating wound. As gas premixed bottles with CO2+ 4% of oxygen and 10% of N2O will be used. This gas will be humidified and at 31-32 °C to be achieved by a commercial humidifier (Fisher and Paykel) programmed in order to maintain 100% relative humidity at 31-32°C upon entrance of the peritoneal cavity. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint : decreased pain on day 1 and 2 after surgery | 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. | 0 to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| decrease in CRP and inflammatory parameters on day 1 and 2 or longer | Postoperative inflammatory reaction : daily assessment of inflammatory parameters as CRP, leucocytosis , and temperature for 4 to 7 days are done routinely today. In some subsets of patients other more specific inflammatory parameters as Ca125, IL-6 can be investigated | day 1-4 |
Not provided
Inclusion criteria :
Exclusion criteria :
Not provided
Not provided
Standard open surgery such as hysterectomy, cancer surgery, bowel resections, cardiac surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe R Koninckx, MD | Contact | +32 16 344202 | pkoninckx@gmail.com | |
| Marleen Craessaerts, RN | Contact | +32 16 343606 | mcraessaerts@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| philippe R Koninckx, MD | UZ Gasthuisberg, KULeuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
Not provided
Not provided
Not provided
Not provided
| lower peritoneal fluid volume on day 2 | Estimation of peritoneal fluid volume by ultrasound on the second day after surgery will be performed in some subsets of patients. We indeed recently validated a non-invasive and reliable assessment of peritoneal fluid volume by ultrasound. (Verguts et all, 2009) We expect that the postoperative peritoneal fluid volume will increase with the degree of peritoneal inflammation. | day 2 after surgery |
| Shorter time to resumption of transit: time to first flatus and time to first stool | Time to first flatus and time to first stool will be recorded | day1 to 5 |