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Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Primary Purpose

Laparoscopic Hysterectomy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Carbon dioxide
full conditioning
Adept
Ringer Lactate
Sponsored by
University Hospital, Gasthuisberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopic Hysterectomy focused on measuring women, laparoscopic subtotal hysterectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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©

Sites / Locations

  • UZ Leuven, campus Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adept

Ringer-lactate

Arm Description

1000ml Adept will be left in the abdomen and measured over time

1000 ml of Ringer lactate left in the abdomen and measured over time

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2011
Last Updated
June 3, 2013
Sponsor
University Hospital, Gasthuisberg
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1. Study Identification

Unique Protocol Identification Number
NCT01344499
Brief Title
Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum
Official Title
Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gasthuisberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Hysterectomy
Keywords
women, laparoscopic subtotal hysterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adept
Arm Type
Experimental
Arm Description
1000ml Adept will be left in the abdomen and measured over time
Arm Title
Ringer-lactate
Arm Type
Active Comparator
Arm Description
1000 ml of Ringer lactate left in the abdomen and measured over time
Intervention Type
Procedure
Intervention Name(s)
Carbon dioxide
Intervention Description
standard pneumoperitoneum with 100% CO2
Intervention Type
Procedure
Intervention Name(s)
full conditioning
Intervention Description
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
Intervention Type
Drug
Intervention Name(s)
Adept
Intervention Description
instillation of 1 liter of fluid at the end of laparoscopy
Intervention Type
Drug
Intervention Name(s)
Ringer Lactate
Intervention Description
instillation of 1 liter of fluid at the end of laparoscopy
Primary Outcome Measure Information:
Title
clearance rate of peritoneal fluid
Description
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.
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
Pain and inflammation score
Description
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
Time Frame
3 days after surgery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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©
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAsper Verguts, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven, campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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