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

NCT01027455 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2010-06-25

No results posted yet for this study

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.

Conditions

  • Peritoneal Dessication Damage and Inflammation
  • Peri-operative Hypothermia

Interventions

DEVICE

Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device

Humidified warm carbon dioxide gas insufflation during laparosopic procedure

PROCEDURE

Laparoscopic Appendicectomy

Dry and Cold carbon dioxide gas insufflation

PROCEDURE

Laparoscopic Appendicectomy

Humidified warm carbon dioxide gas insufflation during laparosopic procedure

Sponsors & Collaborators

  • Auckland District Health Board

    collaborator OTHER_GOV

  • University of Auckland, New Zealand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027455 on ClinicalTrials.gov