Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00642005




Registration number
NCT00642005
Ethics application status
Date submitted
17/03/2008
Date registered
24/03/2008
Date last updated
11/03/2014

Titles & IDs
Public title
Humidification in Laparoscopic Colonic Surgery
Scientific title
Humidification in Laparoscopic Colonic Surgery - A Double Blinded, Randomised Controlled Trial.
Secondary ID [1] 0 0
Laphumid
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Inflammation 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Fisher and Paykel Humidifier (MR860)
Treatment: Surgery - Standard insufflation

Experimental: 1 - Humidified and warmed carbon dioxide laparoscopic insufflation.

Placebo comparator: 2 - Cold and dry carbon dioxide laparoscopic insufflation.


Treatment: Surgery: Fisher and Paykel Humidifier (MR860)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation.

Treatment: Surgery: Standard insufflation
No humidifier or warmer will be used (device switched off). This will deliver laparoscopic insufflate at 0% humidity and 20 degrees C.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain by visual analogue scale
Timepoint [1] 0 0
preop, 2 hours, 4 hours, 8 hours, 12 hours, day 1, day 2, day 3, day 7, day 14, day 30, day 60
Primary outcome [2] 0 0
Morphine equivalent analgesia use
Timepoint [2] 0 0
PACU, day of OT, day 1, day 2, day 3, total in hospital
Secondary outcome [1] 0 0
Intraoperative temperature by esophageal probe
Timepoint [1] 0 0
15 min intervals during surgery
Secondary outcome [2] 0 0
Plasma and peritoneal cytokine concentration
Timepoint [2] 0 0
Morning of surgery
Secondary outcome [3] 0 0
Antiemetic use
Timepoint [3] 0 0
PACU, day of OT, day 1, day 2, day 3
Secondary outcome [4] 0 0
Return of bowel function - passage of flatus, bm, and eating first meal
Timepoint [4] 0 0
daily
Secondary outcome [5] 0 0
Any complications
Timepoint [5] 0 0
Up to 3 months postoperatively
Secondary outcome [6] 0 0
Surgical recovery by SRS
Timepoint [6] 0 0
preop, day 1, day 2, day 3, day 7, day 30, day 60

Eligibility
Key inclusion criteria
* All patients 15 years and over undergoing elective laparoscopic colonic resection at all three auckland hospitals
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute cases
* Stoma formation (preop or intraop decision)
* Decision to change to open surgery preoperatively (intraop conversions included as intention to treat)
* Rectal lesions defined as 15 cm from anal verge on imaging and/or sigmoidoscopy / colonoscopy
* Steroid dependence
* Inability to consent or answer SRS questions due to cognitive impairment or language barrier
* ASA >= 4

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otahuhu
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MBChB, MD, FRACS
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00642005