A randomised controlled trial investigating the effect of humidified warm carbon dioxide (CO2) insufflation during laparoscopic and open abdominal surgery.

Not Applicable

Recruiting

• Conditions: pper Gastrointestinal (GI) Surgery; Hepatobiliary (HPB) Surgery; Upper Gastrointestinal (GI) Surgery; Surgery - Other surgery

• Registration Number: ACTRN12617000850370
• Lead Sponsor: St Vincent's Hospital Melbourne HPB and Upper GI Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-08
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if warm humidified CO2 during laparoscopic and open Upper GI/HPB surgery reduces temperature loss. Outcome will be measured using a nasopharyngeal temperature probe.[Intraoperative and postoperative body temperature will be measured at the beginning and at 15 minute intervals until the end of the operation.]

Secondary Outcome Measures

Name	Time	Method
To determine whether warm humidified CO2 insufflation gas reduces post-operative pain after laparoscopic and open Upper GI/HPB surgery of greater than 2 hour duration. Outcome will be assessed by postoperative pain questionnaire designed for the study, with incorporation of the 100mm visual analogue scale .[Pain assessment will be done postoperatively with pain questionnaire and 100mm visual analogue scale. This must be complete at 24 ± 4 hours postoperatively.<br>];To define the histopathological changes which occur within the peritoneum during Upper GI/HPB surgery and how this is affected by warm humidified CO2 insufflation. This will be assessed by taking 2 small (5x5mm) biopsies of the peritoneum, at two time points (0 and 3 hours intraoperative). Biopsies will only be taken from the first 20 patients (10 from each arm). [Peritoneal biopsy will be taken intraoperative at the beginning and at the end of the surgery, Analysis of the tissue samples will be done postoperatively.]