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Evaluation of Adding Small Amounts of Oxygen to the CO2 Pneumoperitoneum Upon Pain and Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00678366
First received: May 8, 2008
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
Inflammation
 Procedure: addition of 4% oxygen
Procedure: carbon dioxde
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Adding Small Amounts of Oxygen to the CO2 Pneumoperitoneum Upon Pain and Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
addition of 4% oxygen to the carbon dioxide pneumoperitoneum
 Procedure: addition of 4% oxygen
addition of 4% oxygen to the carbon dioxide pneumoperitoneum
Active Comparator: 2
pure carbon dioxide pneumoperitoneum
 Procedure: carbon dioxde
classic pneumoperitoneum with 100 % carbon dioxide

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Immunodeficiency
  • Refuse or unable to sign informed consent
  • Chronic diseases (i.e. COPD, Crohn, cardiac…)
  • Mental diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678366

Locations
Belgium
UZ Leuven, campus gasthuisberg
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Philippe Koninckx, MD, PhD UZ Leuven, campus Gasthuisberg
  More Information

No publications provided

Responsible Party: Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00678366     History of Changes
Other Study ID Numbers: PK-001
Study First Received: May 8, 2008
Last Updated: October 25, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
laparoscopy
carbon dioxide
oxygen
pain
inflammation

Additional relevant MeSH terms:
Inflammation
Pneumoperitoneum
Pathologic Processes
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013