Warm Humid Gas Insufflation for Appendix Removal by Minimally Invasive Surgery Warm Humid Insufflation for Appendix Removal by Minimally Invasive Surgery Trial (WARMIST)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01027455
• Date of registration: 07/12/2009
• Primary sponsor: University of Auckland, New Zealand
• 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) WARMIST
• Scientific title: Warm Humidified Insufflation for Laparoscopic Appendicectomy in Children: a Randomised Controlled Trial
• Date of first enrolment: March 2010
• Target sample size: 190
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01027455
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

New Zealand

Contacts

• Name: James KM Hamill, MBChB, FRACS

• Name: James KM Hamilll, MBChB, FRACS

Key inclusion & exclusion criteria

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.

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



Age minimum: 8 Years
Age maximum: 14 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Peri-operative Hypothermia

Peritoneal Dessication Damage and Inflammation

Intervention(s)

Device: Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device

Procedure: Laparoscopic Appendicectomy

Primary Outcome(s)

Peri-operative Core Body Temperature Variation [Time Frame: Intra-operative, Duration of stay in PACU]

Post-operative Morphine equivalent analgesia use [Time Frame: PACU, Post-operative 12 hours, Post-operative 24 hours, Post-operative 48 hours, Duration of hospital stay]

Secondary Outcome(s)

Pain scores measured by Visual Analogue Scale [Time Frame: Pre-operative baseline and Post-operative 2, 4, 6, 8, 10, 12, 24, 48 hours]

Peri-operative Complications (operative and disease-related) [Time Frame: Up to 6 weeks post-operatively]

Post-operative Return to Normal Daily Activities [Time Frame: Post-operative Day 10 Recovery Questionnaire]

Severity of Laparoscopic Camera Lens Fogging [Time Frame: Intra-operative]

Severity of Post-operative Nausea and Vomiting as indicated by Antiemetic use [Time Frame: Post-operative Day 0, Day 1, Day 2, Day 3]

Secondary ID(s)

WARMIST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Auckland District Health Board