Effect of intraoperative warmed, humidified carbon dioxide insufflation in open laparotomy colorectal surgery patients undergoing Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS HIPEC): a randomized controlled trial (Second WHCO2 trial)
- Conditions
- Colorectal cancerPeritoneal MetastasesCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12623000950662
- Lead Sponsor
- Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Colorectal adenocarcinoma peritoneal metastases confirmed on biopsy at time of diagnostic laparoscopy, Peritoneal cancer index score (diagnostic laparoscopic) <15, Intention to achieve Completeness of cytoreduction score (CCR) of 0. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Extraperitoneal metastasis (current),
Liver metastases,
Non-colorectal adenocarcinoma,
Inability to achieve CCR0,
Inoperable peritoneal carcinomatosis ,
PCI on diagnostic laparoscopy of more than 15,
During laparotomy for CRS/HIPEC, two surgeons agree and decide tumour spread is so advanced that proceeding with operation is futile or too dangerous (however will be analysed as intention to treat),
ECOG score >2,
Charlson Comorbidity index more than 8,
PCI (diagnostic laparoscopic)>16
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method