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Randomized clinical trial of the effect of intraoperative humidified carbon dioxide insufflation in open laparotomy for colorectal resection.

ABSTRACT: BACKGROUND:Animal studies have shown that peritoneal injury can be minimized by insufflating the abdominal cavity with warm humidified carbon dioxide gas. METHODS:A single-blind RCT was performed at a tertiary colorectal unit. Inclusion criteria were patient aged 18?years and over undergoing open elective surgery. The intervention group received warmed (37°C), humidified (98 per cent relative humidity) carbon dioxide (WHCO2 group). Multiple markers of peritoneal inflammation and oxidative damage were used to compare groups, including cytokines and chemokines, apoptosis, the 3-chlorotyrosine/native tyrosine ratio, and light microscopy on peritoneal biopsies at the start (T0 ) and end (Tend ) of the operation. Postoperative clinical outcomes were compared between the groups. RESULTS:Of 40 patients enrolled, 20 in the WHCO2 group and 19 in the control group were available for analysis. A significant log(Tend /T0 ) difference between control and WHCO2 groups was documented for interleukin (IL) 2 (5·3 versus 2·8 respectively; P = 0·028) and IL-4 (3·5 versus 2·0; P = 0·041), whereas apoptosis assays documented no significant change in caspase activity, and similar apoptosis rates were documented along the peritoneal edge in both groups. The 3-chlorotyrosine/tyrosine ratio had increased at Tend by 1·1-fold in the WHCO2 group and by 3·1-fold in the control group. Under light microscopy, peritoneum was visible in 11 of 19 samples from the control group and in 19 of 20 samples from the WHCO2 group (P = 0·006). The only difference in clinical outcomes between intervention and control groups was the number of days to passage of flatus (2·5 versus 5·0?days respectively; P = 0·008). CONCLUSION:The use of warmed, humidified carbon dioxide appears to reduce some markers related to peritoneal oxidative damage during laparotomy. No difference was observed in clinical outcomes, but the study was underpowered for analysis of surgical results. Registration number: NCT02975947 ( www.ClinicalTrials.gov/).

SUBMITTER: Cheong JY

PROVIDER: S-EPMC6996635 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Randomized clinical trial of the effect of intraoperative humidified carbon dioxide insufflation in open laparotomy for colorectal resection.

Cheong J Y JY Chami B B Fong G M GM Wang X S XS Keshava A A Young C J CJ Witting P P

BJS open 20191117 1

<h4>Background</h4>Animal studies have shown that peritoneal injury can be minimized by insufflating the abdominal cavity with warm humidified carbon dioxide gas.<h4>Methods</h4>A single-blind RCT was performed at a tertiary colorectal unit. Inclusion criteria were patient aged 18 years and over undergoing open elective surgery. The intervention group received warmed (37°C), humidified (98 per cent relative humidity) carbon dioxide (WHCO<sub>2</sub> group). Multiple markers of peritoneal inflam ...[more]

PMID: 32011809

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Project description: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

Dataset Information

Randomized clinical trial of the effect of intraoperative humidified carbon dioxide insufflation in open laparotomy for colorectal resection.

Publications

Randomized clinical trial of the effect of intraoperative humidified carbon dioxide insufflation in open laparotomy for colorectal resection.

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