Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Sponsor

University Hospital, Gasthuisberg (Other)

Overall Status

Completed

CT.gov ID

NCT01344499

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Measurement of residual peritoneal fluid after laparoscopic surgery

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Hysterectomy	Procedure: Carbon dioxide Procedure: full conditioning Drug: Adept Drug: Ringer Lactate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

clearance rate of peritoneal fluid [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 Outcome Measures

Pain and inflammation score [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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…)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven, campus Gasthuisberg	Leuven		Belgium	3000

Sponsors and Collaborators

University Hospital, Gasthuisberg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg

ClinicalTrials.gov Identifier:

NCT01344499

Other Study ID Numbers:

S52808

First Posted:

Apr 29, 2011

Last Update Posted:

Jun 4, 2013

Last Verified:

Jun 1, 2013

Keywords provided by Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg

women

laparoscopic subtotal hysterectomy

Additional relevant MeSH terms:

Pneumoperitoneum

Study Results

No Results Posted as of Jun 4, 2013