Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000091303
Ethics application status
Approved
Date submitted
14/02/2008
Date registered
15/02/2008
Date last updated
26/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Laparoscopic Humidification Trial. Warm Humid Insufflation for Laparoscopic Appendicectomy in Children: a Randomised Controlled Trial.
Scientific title
Paediatric Laparoscopic Appendicectomy Humidification Trial: Does Warm Humid Insufflation Gas versus Cool Dry Gas result in Less Post-operative Pain?
Secondary ID [1] 251884 0
WARMIST
Universal Trial Number (UTN)
Trial acronym
WARMIST
Warm humid insufflation for Appendix Removal by Minimally Invasive Surgery Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Appendicectomy 2839 0
Condition category
Condition code
Surgery 2971 2971 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of a laparoscopic humidification device to warm (to body temperature ) and humidify insufflation gas (carbon dioxide) for laparoscopic appendicectomy for the duration of the pneumoperitoneum
Intervention code [1] 2569 0
Treatment: Surgery
Comparator / control treatment
Standard cool (room temperature) dry insufflation gas (carbon dioxide) for laparoscopic appendicectomy for the duration of the pneumoperitoneum
Control group
Active

Outcomes
Primary outcome [1] 3845 0
Number (%) of patients requiring post-operative morphine
Timepoint [1] 3845 0
Within 48 hours of surgery
Primary outcome [2] 3846 0
Dose of morphine used
Timepoint [2] 3846 0
In recovery and at 6 hourly intervals from the end of surgery
Primary outcome [3] 3847 0
Post-operative pain scores
Timepoint [3] 3847 0
At 6 hourly intervals from the end of surgery
Secondary outcome [1] 6479 0
Length of stay in the Post-Anaesthetic Care Unit (PACU)
Timepoint [1] 6479 0
Time at discharge from PACU post-operatively
Secondary outcome [2] 6480 0
Length of hospital stay
Timepoint [2] 6480 0
At discharge from hospital
Secondary outcome [3] 6481 0
The degree of fogging of the laparoscope lens
Timepoint [3] 6481 0
Intraoperative - fogging score completed by surgeon immediately post-operatively

Eligibility
Key inclusion criteria
Children with clinical signs of acute appendicitis undergoing laparoscopic appendicectomy
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded criteria are previous open abdominal surgery, neurological disorder that may interfere with reliable use of patient controlled analgesia device (PCA), an abdominal prostheses such as a gastrostomy or ventriculo-peritoneal shunt, immunosuppression and allergy to morphine.

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)
The surgical registrar / surgeon informs the acute theatre nurse coordinator that the patient will be a trial patient. The coordinator can then ensure the Theatre Trial Pack is available in theatre 2. The randomisation stream – Uncomplicated or Complicated – will need to be communicated to the theatre nursing staff.
The circulating nurse takes the top envelope from the appropriate pile – Uncomplicated or Complicated – and opens the sealed envelope to determine the allocation arm – Humidifier On or Off.
It is essential that the allocation is not revealed to the medical staff or the scrub nurse. It is essential that the allocation is not revealed to the medical staff or the scrub nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator using http://randomization.com. Stratification will take place for clinically generalised peritonitis (complicated) versus clinically localised appendicitis (uncomplicated).
Randomisation allocations placed in sequentially numbered opaque envelopes, a set for each stratification group.
The sequence will be concealed until recruitment is complete.
In theatre, at the request of the surgeon (surgical registrar) the circulating nurse will open the top envelope from either the peritonitis or localised appendicitis pile, as requested.
Prior to insufflation the circulating nurse will turn the humidifier on for patients randomised to the intervention arm, and leave it turned off for control patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment outside Australia
Country [1] 796 0
New Zealand
State/province [1] 796 0

Funding & Sponsors
Funding source category [1] 3095 0
Hospital
Name [1] 3095 0
Auckland District Health Board
Country [1] 3095 0
New Zealand
Primary sponsor type
Individual
Name
James Hamill
Address
Department of Paediatric Surgery
Starship Children's Hospital
Grafton Road, Grafton
Private Bag 92024
Auckland
Country
New Zealand
Secondary sponsor category [1] 2783 0
Hospital
Name [1] 2783 0
Auckland District Health Board
Address [1] 2783 0
Private Bag 92024
Auckland
Country [1] 2783 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5040 0
Ethics committee address [1] 5040 0
Ethics committee country [1] 5040 0
Date submitted for ethics approval [1] 5040 0
15/02/2008
Approval date [1] 5040 0
Ethics approval number [1] 5040 0

Summary
Brief summary
In laparoscopic surgery, the use of dry, cold insufflation gas (to inflate the abdominal cavity for a clear view of operating field) results in the drying of the lining of the cavity, which has been suggested to be a negative determinant of length of recovery. Adult studies using warm humidified insufflation gas were suggestive of decreased post-operative pain, decreased fogging of the camera lens, decreased operative time and decreased length of Post-Anaesthetic Care Unit (PACU) stay - although findings were variable. No such studies have been done in children. This study will be the first in the paediatric population, aiming to measure; post-operative pain using the amount of PCA (patient controlled analgesia) morphine use; pain score; length of PACU and hospital stay and fogging of camera using Laparoscopic Fogging Criteria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28377 0
Address 28377 0
Country 28377 0
Phone 28377 0
Fax 28377 0
Email 28377 0
Contact person for public queries
Name 11534 0
James Hamill
Address 11534 0
Department of Paediatric Surgery
Starship Children's Hospital
Private Bag 92024
Auckland
Country 11534 0
New Zealand
Phone 11534 0
+64 9 3074949
Fax 11534 0
Email 11534 0
[email protected]
Contact person for scientific queries
Name 2462 0
James Hamill
Address 2462 0
Department of Paediatric Surgery
Starship Children's Hospital
Private Bag 92024
Auckland
Country 2462 0
New Zealand
Phone 2462 0
+64 9 3074949
Fax 2462 0
Email 2462 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.