CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Completed
NCT Number: NCT01887028
Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment
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.
Completed
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Notify MeKey information
Age range
45 year–75 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 45-75 years old
- Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
- Menopaused
- ASA class I or II
Exclusion criteria
- Absolute contraindications to laparoscopy
- Previous history of pelvic surgery, endometriosis and/or infection
- Pathological peritoneal tissue
- BMI more than 30
- Height less than 150cm
Treatment and study plan
Fisher and Paykel Humidifier (MR860AEU)
DeviceHumidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
Primary outcomes
-
Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues
Time frame: at1 hour and 2 hours (day 1)
Secondary outcomes
-
Quality of post-operative recovery
Time frame: at day 1
-
Post-operative pain
Time frame: at day 1
-
Per or post operative complications
Time frame: at day 1
-
Intraoperative core temperature
Time frame: at day 1
Sponsors and collaborators
Lead sponsor
University Hospital, Clermont-Ferrand
Other
Registry information
Official study title
A Single-blind, Randomized Study to Compare Impacts of Intraperitoneal Pressure (8mmHg Versus 12 mmHg) and CO2 Gas (Cool, Dry CO2 Gas Versus Warmed; Humidified Co2 Gas) on Surgical Peritoneal Environment During Laparoscopic Surgery
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Jun 26, 2013
- Registry last updated
- Jul 19, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.