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
Recruitment status was Recruiting
Sponsor:
University of Auckland, New Zealand
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
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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
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 Signs and Symptoms Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013