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OpenTrials
Completed

NCT Number: NCT01344499

Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Measurement of residual peritoneal fluid after laparoscopic surgery

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Key information

Conditions

Laparoscopic Hysterectomy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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©

Treatment and study plan

Carbon dioxide

Procedure

standard pneumoperitoneum with 100% CO2

full conditioning

Procedure

Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C

Adept

Drug

instillation of 1 liter of fluid at the end of laparoscopy

Ringer lactate

Drug

instillation of 1 liter of fluid at the end of laparoscopy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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