Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000287538
Ethics application status
Approved
Date submitted
22/03/2006
Date registered
7/07/2006
Date last updated
7/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of heated, humidified CO2 on post operative pan and recovery times in patients having laparoscopic surgery lasting for greater than 90 minutes - a randomised, controlled trial
Scientific title
The effect of heated, humidified CO2 on post operative pain and recovery times in patients having laparoscopic surgery lasting for greater than 90 minutes - a randomised, controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain and recovery 1262 0
Condition category
Condition code
Surgery 1348 1348 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of humidified, heated carbon dioxide for laparoscopy for the duration of the procedure. Humidification occuring via the Fisher and Paykel Humidification System.
Intervention code [1] 949 0
Treatment: Other
Comparator / control treatment
Use of cold, dry carbon dioxide (usual practice)
Control group
Active

Outcomes
Primary outcome [1] 1838 0
Post operative pain scores
Timepoint [1] 1838 0
At 1, 2 and 4 hours
Secondary outcome [1] 3221 0
Post operative analgesia use days 1,2,3 post op.
Timepoint [1] 3221 0
Secondary outcome [2] 3222 0
Post operative body temperature (in recovery ie immediately post op)
Timepoint [2] 3222 0
Secondary outcome [3] 3223 0
Time in hospital
Timepoint [3] 3223 0

Eligibility
Key inclusion criteria
Undergoing gynaecological operative laparoscopy lasting greater than 90 minutes
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women having shorter operative laparoscopies, major procedures such as hysterectimy, colpotomy or myomectomy, any contraindication to the standard anaesthetic medications or analgesic medic cations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1475 0
Self funded/Unfunded
Name [1] 1475 0
Country [1] 1475 0
Funding source category [2] 1476 0
Commercial sector/Industry
Name [2] 1476 0
Fisher and Paykel
Country [2] 1476 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel
Address
Country
New Zealand
Secondary sponsor category [1] 1302 0
None
Name [1] 1302 0
Nil
Address [1] 1302 0
Country [1] 1302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2857 0
Mercy Hospital for Women Melbourne
Ethics committee address [1] 2857 0
Ethics committee country [1] 2857 0
Australia
Date submitted for ethics approval [1] 2857 0
Approval date [1] 2857 0
Ethics approval number [1] 2857 0
R06/12

Summary
Brief summary
The purpose of the study is to determine whether the use of heated, humidified carbon dioxide during laparoscopy lasting greater than 90 minutes results in less pain and shorter hospital stay than using cold, dry carbon dioxide (which is currently standardly used). Animal models show that use of cold, dry gas results in drying and damage to the cells in the lining of the abdomen, whereas using heated, humidified gas prevents this from occuring. Some human studies have shown that the heated, humidified gas results in less post-operative pain. Both the patients and the post-operative nursing staff will be blinded to the type of gas used. Patients will blinded to the type of gas used as randomisation occurs once they are under the anaesthetic. The type of gas used will not be recorded in the research notes and as such, the nursing staff will not be aware of the type of gas used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36016 0
Address 36016 0
Country 36016 0
Phone 36016 0
Fax 36016 0
Email 36016 0
Contact person for public queries
Name 10138 0
Dr Melissa Cameron
Address 10138 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 10138 0
Australia
Phone 10138 0
+61 3 84584901
Fax 10138 0
+61 3 84584878
Email 10138 0
[email protected]
Contact person for scientific queries
Name 1066 0
Dr Melissa Cameron
Address 1066 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 1066 0
Australia
Phone 1066 0
+61 3 84584901
Fax 1066 0
+61 3 84584878
Email 1066 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.