NCT00678366

Brief Summary

The study intends to investigate the use of a novel gaz-composition used during laparoscopy upon pain and inflammation in the post-operative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started May 2008

Typical duration for phase_3 pain

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

May 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

2.3 years

First QC Date

May 8, 2008

Last Update Submit

October 25, 2011

Conditions

PainInflammation

Keywords

laparoscopycarbon dioxideoxygenpaininflammation

Outcome Measures

Primary Outcomes (1)

  • to check if the post-operative pain and inflammatory reaction after laparoscopy decreases when CO2 with the addition of 4% of oxygen is used instead of pure CO2

    1 week

Secondary Outcomes (1)

  • the effects on CO2 resorbtion, pain and inflammation by co-variables: body mass index, length of surgery, painkiller intake and pain before surgery as defined by the Biberoglu and Behrman scale

    1 week

Study Arms (2)

1

EXPERIMENTAL

addition of 4% oxygen to the carbon dioxide pneumoperitoneum

Procedure: addition of 4% oxygen

2

ACTIVE COMPARATOR

pure carbon dioxide pneumoperitoneum

Procedure: carbon dioxde

Interventions

addition of 4% oxygenPROCEDURE

addition of 4% oxygen to the carbon dioxide pneumoperitoneum

1
carbon dioxdePROCEDURE

classic pneumoperitoneum with 100 % carbon dioxide

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has signed a written informed consent to participate in the study and has agreed to follow instructions and complete all required questionnaires
  • Females, 18 years of age or older
  • She has to undergo a planned laparoscopy for mentioned indications with a duration that exceeds 60 minutes

You may not qualify if:

  • Pregnancy
  • Immunodeficiency
  • Refuse or unable to sign informed consent
  • Chronic diseases (i.e. COPD, Crohn, cardiac…)
  • Mental diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven, campus gasthuisberg

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

PainInflammation

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Philippe Koninckx, MD, PhD

    UZ Leuven, campus Gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 15, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

BE(1)