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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)

ABSTRACT: Interventions: Patients in the intervention group will receive warmed (37°C), humidified (98% RH) carbon dioxide. The delivered gas will be defined by the United States Pharmacopeia and National Formulary, which requires impurity of less than 200 parts per million, including water vapour. The gas diffuser will be positioned inside the open abdominal wound cavity (in the epigastric region) at a depth of approximately 4cm from the skin as soon as the abdominal wall retraction has been done. The insufflation of warm humidified CO2 will then start and continue until the abdominal wall retractors are removed and closure of the abdominal wall is commenced (approx. a few hours). The intervention will be delivered by the anaesthesiologist and operation reports will be monitored to ensure consistency in administration of intervention. This medical grade CO2 will be warmed to 37°C and humidified to 98% RH using a humidification system. The HUMIGARD system kits are individually packaged in a sterile manner. Primary outcome(s): The primary outcome of interest is the 5-year overall survival /disease free survival. Disease free status will be monitored by regular intervals of colonoscopy, CT scans and tumour marker levels. These are composite primary outcomes.[ Colonoscopies to be done at 1 year and 4 years post surgery, CT scans will be done at 6 monthly intervals till year 3 then yearly thereafter to 5 years post surgery and tumour markers (CEA, CA19.9 and CA125) will be assessed 3 monthly till year 3, then 6 monthly thereafter until 5 years post surgery.];Peritoneal damage will be assessed using various methods and be used to see if there is a correlation between survival and the peritoneal damage. Peritoneum will examined by light microscopy following staining with Haematoxylin and Eosin (H&E). Levels of inflammatory cytokines and chemokines will measured using a commercial ELISA kit. To assess oxidative peritoneal protein damage, the level of 3-chlorotyrosine and total native tyrosine in the peritoneal homogenates will be measured using high-pressure liquid chromatography with mass spectrometry (HPLC-MS). Also using immunohistochemistry, antibodies against MDA and other lipid oxidation products will be measured. Cell-apoptosis will be measured by the detection of active caspase-3/7 bioluminescence assayed in the stored tissue homogenates with Casapse-Glo 3/7 Assay. A second marker of cell viability will be determined using the DeadEndTM Fluorometric TUNEL System. The extent of DNA fragmentation will be quantified through the measurement of green fluorescence intensity with a fluorescence microscopy. These outcomes will be assessed as a composite primary outcome. [ These will be measured from samples taken intraoperatively.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Peritoneal Metastases

PROVIDER: 93916 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Delivery of warmed, humidified CO2 to the peritoneal cavity during laparoscopic and open abdominal colorectal cancer surgery. Participants in the study group will receive warmed (37 degrees Celsius), humidified (98%) CO2 via insufflation in the minimally invasive group or wound insufflation in the open group. The HumiGardTM humidification system (MR860; Fisher and Paykel Health Care, Auckland, New Zealand) has been independently tested to confirm the effectiveness of gas humidification. Anticipated duration of surgery for any group is between 2 to 4 hours. For both laparoscopic surgery groups, pneumoperitoneum will be established after insertion of a 12mm port by open method. Further 10mm and 5mm ports will be inserted according to the type of laparoscopic procedure. The laparoscopic control group will receive non humidified unwarmed CO2 delivered by a standard insufflator. For the study laparoscopic group the insufflation tubing will include the humidification system consists of a bacterial filter and a humidification chamber filled with 180 mL sterile water, attached to a humidifier controller that includes an integrated temperature and flow sensor. The outlet of the humidification chamber is connected to a thermally insulated 2.5m long heated insufflation tube that maintains temperature and humidity of the gas to its outlet. In the open group dry CO2 is delivered via a 6.35mm polyvinylchloride tube to the open surgery humidification system (F&P HumiGard, Fisher & Paykel Healthcare Ltd, Auckland, New Zealand). This is attached to flexible tubing and positioned inside the open abdominal wound cavity in the right upper quadrant, a depth of approximately 4 cm from the skin. Insufflation of warmed, humidified CO2 will be continued from the time the lapa Primary outcome(s): Assessment of peritoneal tissue damage, as measured by peritoneal morphological changes. [Peritoneal fluid and peritoneal biopsies will be taken at the start of the operation, then 2-hourly intra-operatively. ] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

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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)

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