Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment
NCT ID: NCT01887028
Last Updated: 2016-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2013-07-31
2016-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SINGLE
Study Groups
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12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20)
Fisher and Paykel Humidifier (MR860AEU)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
12mmHg intraperitoneal pressure (warmed, humidified CO2 gas)
Fisher and Paykel Humidifier (MR860AEU)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20)
Fisher and Paykel Humidifier (MR860AEU)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
8mmHg intraperitoneal pressure (warmed, humidified CO2 gas)
Fisher and Paykel Humidifier (MR860AEU)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
Interventions
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Fisher and Paykel Humidifier (MR860AEU)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
Eligibility Criteria
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Inclusion Criteria
* Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
* Menopaused
* ASA class I or II
Exclusion Criteria
* Previous history of pelvic surgery, endometriosis and/or infection
* Pathological peritoneal tissue
* BMI more than 30
* Height less than 150cm
45 Years
75 Years
FEMALE
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Revaz BOTCHORISHVILI
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Other Identifiers
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CHU-0158
Identifier Type: -
Identifier Source: org_study_id
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