None listed
Conditions
Brief summary
The current study aims to investigate the effect of using warm and humidified carbon dioxide (CO2) gas instead of cold dry CO2 (standard of care) during laparoscopic surgery, and the insufflation of warmed humidified CO2 during open abdominal surgery, The Study will be a single blinded randomized controlled study and participants will be recruited from patients undertaking laparoscopic or open abdominal surgery. Primary outcome will be the effect of using warm humidified CO2 insufflation gas on body temperature with histopathological changes to the peritoneum and post-operative pain being measured as secondary outcomes. Clinical benefit will be assessed by measuring post-operative pain, using a post-operative pain questionnaire, temperature to assess for hypothermia and analyses of peritoneal biopsies taken at the beginning and just prior to conclusion of the operations. It is expected that warm and humidified CO2 will reduce hypothermia and peritoneal damage, and improve post-operative pain.
Interventions
This study involves the use of warm humidified Carbon Dioxide (CO2) insufflation in Upper GI and HPB surgery. There are two study arms, each with two groups. Patients in each arm will be randomized into either one of the two groups.
Arm 1: Laparoscopic surgery
Arm 1 - Group 1: Warm humidified CO2
Arm1 - Group 2: Dry room temperature CO2 (standard of care)
Arm 2: Open surgery
Arm 2 - Group 1: Warm humidified CO2
Arm 2- Group 2: No intracorporeal warming
Warmed humidified CO2 will be delivered
This study involves the use of warm humidified Carbon Dioxide (CO2) insufflation in Upper GI and HPB surgery. There are two study arms, each with two groups. Patients in each arm will be randomized into either one of the two groups. Arm 1: Laparoscopic surgery Arm 1 - Group 1: Warm humidified CO2 Arm1 - Group 2: Dry room temperature CO2 (standard of care) Arm 2: Open surgery Arm 2 - Group 1: Warm humidified CO2 Arm 2- Group 2: No intracorporeal warming Warmed humidified CO2 will be delivered into open peritoneal cavity during open surgery, and use for insufflation of peritoneal cavity during laparoscopic surgery. This will be delivered to Group 1 of Arm 1 and 2 by operating surgeon in theatre. Humidification device - HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) will be used throughout the surgery session (from first incision until completion of surgery). CO2 gas will be warmed to 37 degrees Celsius and humidity will be at 100% RH. An external warming device (upper body Bair Hugger) will be set to 38 degree Celsius and will be used on all participants. All fluids administered to the participants during the operation will be warmed using the BIEGLER medizin elektronik BW 585 warmer at 40 degree Celsius. Small 5x5mm excisional biopsies from the right paracolic will be taken at the start and just prior to the completion of the operation in the first 10 patients of each arm. These biopsy will then be analysed to identify any histological markers of inflammation. All staff member involve in the surgery will be notify of the protocol requirements, in particular theatre technicians and anesthetists. Adherence will be maintained by implementation of checklists. A research coordinator will be employed to ensures that all parties involved adhere to the protocol.
Sponsors
St Vincent's Hospital Melbourne HPB and Upper GI Research Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undertaking elective Upper GI or HPB surgery of longer than 2 hours duration at St Vincent's Hospital, Melbourne.
Exclusion criteria
- Women who are pregnant and the human fetus - Children and/or young people (ie. <18 years)
Outcome results
None listed