NCT01344499

Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Gasthuisberg · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

Measurement of residual peritoneal fluid after laparoscopic surgery

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.

Conditions

• Laparoscopic Hysterectomy

Interventions

Type	Name	Description
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
DRUG	Ringer Lactate	instillation of 1 liter of fluid at the end of laparoscopy

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-04-29
• Last updated: 2013-06-04

Locations

1 site across 1 country: Belgium