Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum
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Purpose
Measurement of residual peritoneal fluid after laparoscopic surgery
| Condition | Intervention |
|---|---|
|
Hysterectomy |
Procedure: Carbon dioxide Procedure: full conditioning Drug: Adept Drug: Ringer Lactate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum |
- clearance rate of peritoneal fluid [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]We will estimate the residual volume of fluid in the abdominal cavity in a 30° anti-Trendelenburg position after 1 minute in this position. Measurements will be repeated daily until discharge.
- Pain and inflammation score [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
Postoperative pain will be assessed by the intake of ibuprofen or other pain killers and by Visual Analog Scale (VAS). Patients will be asked to locate their pain-symptoms (shoulder, subcostal, trocar wound and visceral pain) and score the severity. VAS will be collected 2-4 hours after surgery and every post-operative day until discharge.
Daily routine blood samples will be obtained and CRP will be measured. Routinely time of first flatus or stools will be recorded
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Adept
1000ml Adept will be left in the abdomen and measured over time
|
Procedure: Carbon dioxide
standard pneumoperitoneum with 100% CO2
Procedure: full conditioning
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
Drug: Adept
instillation of 1 liter of fluid at the end of laparoscopy
|
|
Active Comparator: Ringer-lactate
1000 ml of Ringer lactate left in the abdomen and measured over time
|
Procedure: Carbon dioxide
standard pneumoperitoneum with 100% CO2
Procedure: full conditioning
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
Drug: Ringer Lactate
instillation of 1 liter of fluid at the end of laparoscopy
|
Detailed Description:
Primary endpoints
- 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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
- No limitation in body mass index or uterine size is made.
Exclusion Criteria:
- pregnancy
- immunodeficiency
- refuse or unable to sign informed consent
- chronic disease (i.e. COPD, Crohn, cardiac…)
- known allergy for Adept©
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg |
| ClinicalTrials.gov Identifier: | NCT01344499 History of Changes |
| Other Study ID Numbers: | S52808 |
| Study First Received: | April 21, 2011 |
| Last Updated: | October 25, 2011 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Gasthuisberg:
|
women laparoscopic subtotal hysterectomy |
Additional relevant MeSH terms:
|
Pneumoperitoneum Peritoneal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013