Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

June 3, 2013 updated by: Jasper Verguts, University Hospital, Gasthuisberg

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

Measurement of residual peritoneal fluid after laparoscopic surgery

Study Overview

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • UZ Leuven, Campus Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adept
1000ml Adept will be left in the abdomen and measured over time
standard pneumoperitoneum with 100% CO2
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
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
standard pneumoperitoneum with 100% CO2
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
instillation of 1 liter of fluid at the end of laparoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and inflammation score
Time Frame: 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

3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JAsper Verguts, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (ESTIMATE)

April 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • S52808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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