Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Study Overview
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Brief Summary
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Measurement of residual peritoneal fluid after laparoscopic surgery

Detailed Description
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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.

Official Title
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Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum

Conditions
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Laparoscopic Hysterectomy

Intervention / Treatment
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* Procedure: Carbon dioxide
* Procedure: full conditioning
* Drug: Adept
* Drug: Ringer Lactate


Participation Criteria
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Eligibility Criteria
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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©
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adept<br>1000ml Adept will be left in the abdomen and measured over time | Procedure: Carbon dioxide<br>* standard pneumoperitoneum with 100% CO2<br>Procedure: full conditioning<br>* Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C<br>Drug: Adept<br>* instillation of 1 liter of fluid at the end of laparoscopy<br>|
| Active Comparator: Ringer-lactate<br>1000 ml of Ringer lactate left in the abdomen and measured over time | Procedure: Carbon dioxide<br>* standard pneumoperitoneum with 100% CO2<br>Procedure: full conditioning<br>* Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C<br>Drug: Ringer Lactate<br>* instillation of 1 liter of fluid at the end of laparoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance rate of peritoneal fluid | 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. | 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and inflammation score | 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 | 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, laparoscopic subtotal hysterectomy