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Use lay language.
The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.
Patients undergoing laparoscopic hysterectomy with promontofixation are randomized into four groups: Group 1: 12mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 2: 12mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20), Group 3: 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 4: 8mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20).
Normal peritoneum is collected from the parietal wall at the beginning of laparoscopic surgery and at 1 and 2 hours. Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signaling molecules in peritoneal tissues are measured by real-time PCR.
Quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, per or post operative complications and intraoperative core temperature are assessed and compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20) | Experimental |
| |
| 12mmHg intraperitoneal pressure (warmed, humidified CO2 gas) | Other |
| |
| 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20) | Other |
| |
| 8mmHg intraperitoneal pressure (warmed, humidified CO2 gas) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisher and Paykel Humidifier (MR860AEU) | Device | Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues | at1 hour and 2 hours (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of post-operative recovery | at day 1 | |
| Post-operative pain | at day 1 | |
| Per or post operative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Revaz BOTCHORISHVILI | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| at day 1 |
| Intraoperative core temperature | at day 1 |