Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum
NCT ID: NCT01344499
Last Updated: 2013-06-04
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
20 participants
INTERVENTIONAL
2009-08-31
2011-09-30
Brief Summary
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Detailed Description
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* to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept \~30-60 ml/h)
* to evaluate the role of the mesothelial barrier in this clearance rate.
Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane
Secondary endpoints:
-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Adept
1000ml Adept will be left in the abdomen and measured over time
Carbon dioxide
standard pneumoperitoneum with 100% CO2
full conditioning
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
Adept
instillation of 1 liter of fluid at the end of laparoscopy
Ringer-lactate
1000 ml of Ringer lactate left in the abdomen and measured over time
Carbon dioxide
standard pneumoperitoneum with 100% CO2
full conditioning
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
Ringer Lactate
instillation of 1 liter of fluid at the end of laparoscopy
Interventions
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Carbon dioxide
standard pneumoperitoneum with 100% CO2
full conditioning
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
Adept
instillation of 1 liter of fluid at the end of laparoscopy
Ringer Lactate
instillation of 1 liter of fluid at the end of laparoscopy
Eligibility Criteria
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Inclusion Criteria
* No limitation in body mass index or uterine size is made.
Exclusion Criteria
* immunodeficiency
* refuse or unable to sign informed consent
* chronic disease (i.e. COPD, Crohn, cardiac…)
* known allergy for Adept©
FEMALE
Yes
Sponsors
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University Hospital, Gasthuisberg
OTHER
Responsible Party
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Jasper Verguts
MD, PhD
Principal Investigators
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JAsper Verguts, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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UZ Leuven, campus Gasthuisberg
Leuven, , Belgium
Countries
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Other Identifiers
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S52808
Identifier Type: -
Identifier Source: org_study_id
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