NCT01344499

Brief Summary

Measurement of residual peritoneal fluid after laparoscopic surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

2.1 years

First QC Date

April 21, 2011

Last Update Submit

June 3, 2013

Conditions

Laparoscopic Hysterectomy

Keywords

womenlaparoscopic subtotal hysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days after surgery

Secondary Outcomes (1)

  • Pain and inflammation score

    3 days after surgery

Study Arms (2)

Adept

EXPERIMENTAL

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

Procedure: Carbon dioxideProcedure: full conditioningDrug: Adept

Ringer-lactate

ACTIVE COMPARATOR

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

Procedure: Carbon dioxideProcedure: full conditioningDrug: Ringer Lactate

Interventions

Carbon dioxidePROCEDURE

standard pneumoperitoneum with 100% CO2

AdeptRinger-lactate
full conditioningPROCEDURE

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

AdeptRinger-lactate
AdeptDRUG

instillation of 1 liter of fluid at the end of laparoscopy

Adept
Ringer LactateDRUG

instillation of 1 liter of fluid at the end of laparoscopy

Ringer-lactate

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy
  • immunodeficiency
  • refuse or unable to sign informed consent
  • chronic disease (i.e. COPD, Crohn, cardiac…)
  • known allergy for Adept©

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Carbon DioxideRinger's Lactate

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • JAsper Verguts, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 29, 2011

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

BE(1)