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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Auckland, New Zealand.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Auckland District Health Board
Information provided by:
University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT01027455
First received: December 7, 2009
Last updated: June 24, 2010
Last verified: October 2009
  Purpose

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.


Condition Intervention
Peritoneal Dessication Damage and Inflammation
Peri-operative Hypothermia
Device: Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device
Procedure: Laparoscopic Appendicectomy

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
Official Title: Warm Humidified Insufflation for Laparoscopic Appendicectomy in Children: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Peri-operative Core Body Temperature Variation [ Time Frame: Intra-operative, Duration of stay in PACU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores measured by Visual Analogue Scale [ Time Frame: Pre-operative baseline and Post-operative 2, 4, 6, 8, 10, 12, 24, 48 hours ] [ Designated as safety issue: No ]
  • Post-operative Return to Normal Daily Activities [ Time Frame: Post-operative Day 10 Recovery Questionnaire ] [ Designated as safety issue: No ]
  • Severity of Post-operative Nausea and Vomiting as indicated by Antiemetic use [ Time Frame: Post-operative Day 0, Day 1, Day 2, Day 3 ] [ Designated as safety issue: No ]
  • Peri-operative Complications (operative and disease-related) [ Time Frame: Up to 6 weeks post-operatively ] [ Designated as safety issue: Yes ]
  • Severity of Laparoscopic Camera Lens Fogging [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Dry Cold
Dry (0% relative humidity) and cold (20 degrees Celsius - Room Temperature) carbon dioxide gas intraperitoneal insufflation for laparoscopic appendicectomy
Procedure: Laparoscopic Appendicectomy
Dry and Cold carbon dioxide gas insufflation
Experimental: Humidification
Humidified (98% relative humidity) and warm (37 degrees Celsius) carbon dioxide gas intraperitoneal insufflation for laparoscopic appendicectomy
Device: Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device
Humidified warm carbon dioxide gas insufflation during laparosopic procedure
Procedure: Laparoscopic Appendicectomy
Humidified warm carbon dioxide gas insufflation during laparosopic procedure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027455

Contacts
Contact: James KM Hamilll, MBChB, FRACS +64 9 3797440 ext 6381 jamesh@adhb.govt.nz
Contact: Tzu-Chieh Wendy - Yu, MBChB + 64 9 276 0076 ext - wendells9@gmail.com

Locations
New Zealand
Starship Children's Hospital Recruiting
Auckland, New Zealand
Contact: James KM Hamill, MBChB, FRACS    +64 9 3797440 ext 6381    jamesh@adhb.govt.nz   
Contact: Tzu-Chieh Wendy - Yu, MBChB    + 64 9 276 0076 ext -    wendells9@gmail.com   
Principal Investigator: James KM Hamill, MBChB, FRACS         
Sub-Investigator: Tzu-Chieh Wendy Yu, MBChB         
Sponsors and Collaborators
University of Auckland, New Zealand
Auckland District Health Board
  More Information

No publications provided by University of Auckland, New Zealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr James KM Hamill, Auckland District Health Board
ClinicalTrials.gov Identifier: NCT01027455     History of Changes
Other Study ID Numbers: WARMIST
Study First Received: December 7, 2009
Last Updated: June 24, 2010
Health Authority: New Zealand: Northern X Regional Ethics Committee, Ministry of Health
New Zealand: Auckland District Health Board Research Review Committee

Additional relevant MeSH terms:
Hypothermia
Inflammation
Body Temperature Changes
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014