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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01027455




Registration number
NCT01027455
Ethics application status
Date submitted
7/12/2009
Date registered
8/12/2009
Date last updated
25/06/2010

Titles & IDs
Public title
Warm Humid Gas Insufflation for Appendix Removal by Minimally Invasive Surgery Warm Humid Insufflation for Appendix Removal by Minimally Invasive Surgery Trial (WARMIST)
Scientific title
Warm Humidified Insufflation for Laparoscopic Appendicectomy in Children: a Randomised Controlled Trial
Secondary ID [1] 0 0
WARMIST
Universal Trial Number (UTN)
Trial acronym
WARMIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Dessication Damage and Inflammation 0 0
Peri-operative Hypothermia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device
Treatment: Surgery - Laparoscopic Appendicectomy
Treatment: Surgery - Laparoscopic Appendicectomy

Placebo comparator: Dry Cold - Dry (0% relative humidity) and cold (20 degrees Celsius - Room Temperature) carbon dioxide gas intraperitoneal insufflation for laparoscopic appendicectomy

Experimental: Humidification - Humidified (98% relative humidity) and warm (37 degrees Celsius) carbon dioxide gas intraperitoneal insufflation for laparoscopic appendicectomy


Treatment: Devices: Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device
Humidified warm carbon dioxide gas insufflation during laparosopic procedure

Treatment: Surgery: Laparoscopic Appendicectomy
Dry and Cold carbon dioxide gas insufflation

Treatment: Surgery: Laparoscopic Appendicectomy
Humidified warm carbon dioxide gas insufflation during laparosopic procedure
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-operative Morphine equivalent analgesia use
Timepoint [1] 0 0
PACU, Post-operative 12 hours, Post-operative 24 hours, Post-operative 48 hours, Duration of hospital stay
Primary outcome [2] 0 0
Peri-operative Core Body Temperature Variation
Timepoint [2] 0 0
Intra-operative, Duration of stay in PACU
Secondary outcome [1] 0 0
Pain scores measured by Visual Analogue Scale
Timepoint [1] 0 0
Pre-operative baseline and Post-operative 2, 4, 6, 8, 10, 12, 24, 48 hours
Secondary outcome [2] 0 0
Post-operative Return to Normal Daily Activities
Timepoint [2] 0 0
Post-operative Day 10 Recovery Questionnaire
Secondary outcome [3] 0 0
Severity of Post-operative Nausea and Vomiting as indicated by Antiemetic use
Timepoint [3] 0 0
Post-operative Day 0, Day 1, Day 2, Day 3
Secondary outcome [4] 0 0
Peri-operative Complications (operative and disease-related)
Timepoint [4] 0 0
Up to 6 weeks post-operatively
Secondary outcome [5] 0 0
Severity of Laparoscopic Camera Lens Fogging
Timepoint [5] 0 0
Intra-operative

Eligibility
Key inclusion criteria
* Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/- appendicectomy.
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery

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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2011
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Auckland District Health Board
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the abdominal cavity for the creation a clear operating field, results in damage to the cavity lining, known as the peritoneum. This has been associated with negative effects on post-operative recovery. Adult studies using warm humidified insufflation gas have indicated possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased fogging of the laparoscopic camera lens, and reduced time to return to normal activities. Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in body core temperature (hypothermia). This has been established by trials in adult humans and animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation during laparoscopic removal of the appendix in children reduces intraoperative temperature variations, post-operative pain (indicated by morphine usage and pain scores), length of hospital stay and degree of camera lens fogging, and speed post-operative recovery compared to using cold dry gas insufflation.
Trial website
https://clinicaltrials.gov/study/NCT01027455
Trial related presentations / publications
Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James KM Hamilll, MBChB, FRACS
Address 0 0
Country 0 0
Phone 0 0
+64 9 3797440
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01027455