Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Not Applicable

Completed

• Conditions: Laparoscopic Hysterectomy
• Interventions: Procedure: Carbon dioxide; Procedure: full conditioning; Drug: Ringer Lactate; Drug: Adept

• Registration Number: NCT01344499
• Lead Sponsor: University Hospital, Gasthuisberg

Brief 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-29
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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©

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adept	Carbon dioxide	1000ml Adept will be left in the abdomen and measured over time
Ringer-lactate	Ringer Lactate	1000 ml of Ringer lactate left in the abdomen and measured over time
Adept	Adept	1000ml Adept will be left in the abdomen and measured over time
Adept	full conditioning	1000ml Adept will be left in the abdomen and measured over time
Ringer-lactate	full conditioning	1000 ml of Ringer lactate left in the abdomen and measured over time
Ringer-lactate	Carbon dioxide	1000 ml of Ringer lactate left in the abdomen and measured over time

Primary Outcome Measures

Name	Time	Method
clearance rate of peritoneal fluid	3 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Pain and inflammation score	3 days after surgery	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

Trial Locations

Locations (1)

UZ Leuven, campus Gasthuisberg; 🇧🇪 Leuven, Belgium