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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014