Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01344499
First received: April 21, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

Measurement of residual peritoneal fluid after laparoscopic surgery


Condition Intervention
Laparoscopic Hysterectomy
Procedure: Carbon dioxide
Procedure: full conditioning
Drug: Adept
Drug: Ringer Lactate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • clearance rate of peritoneal fluid [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
    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:
  • Pain and inflammation score [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]

    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



Enrollment: 20
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adept
1000ml Adept will be left in the abdomen and measured over time
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
Active Comparator: Ringer-lactate
1000 ml of Ringer lactate left in the abdomen and measured over time
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: Ringer Lactate
instillation of 1 liter of fluid at the end of laparoscopy

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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©
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344499

Locations
Belgium
UZ Leuven, campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: JAsper Verguts, MD, PhD UZ Leuven
  More Information

No publications provided

Responsible Party: Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01344499     History of Changes
Other Study ID Numbers: S52808
Study First Received: April 21, 2011
Last Updated: June 3, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
women
laparoscopic subtotal hysterectomy

Additional relevant MeSH terms:
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 16, 2014