Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344499
• Other study ID #: S52808
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: June 3, 2013
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Measurement of residual peritoneal fluid after laparoscopic surgery

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy
• Pneumoperitoneum

Intervention

Procedure:
• Carbon dioxide
standard pneumoperitoneum with 100% CO2
• 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
• Ringer Lactate
instillation of 1 liter of fluid at the end of laparoscopy

Locations

Country	Name	City	State
Belgium	UZ Leuven, campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No