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Effects of low intraperitoneal pressure and a warmed, humidified carbon dioxide gas in laparoscopic surgery: a randomized clinical trial.

ABSTRACT: Laparoscopic surgery technology continues to advance. However, much less attention has been focused on how alteration of the laparoscopic surgical environment might improve clinical outcomes. We conducted a randomized, 2?×?2 factorial trial to evaluate whether low intraperitoneal pressure (IPP) (8?mmHg) and/or warmed, humidified CO2 (WH) gas are better for minimizing the adverse impact of a CO2 pneumoperitoneum on the peritoneal environment during laparoscopic surgery and for improving clinical outcomes compared to the standard IPP (12?mmHg) and/or cool and dry CO2 (CD) gas. Herein we show that low IPP and WH gas may decrease inflammation in the laparoscopic surgical environment, resulting in better clinical outcomes. Low IPP and/or WH gas significantly lowered expression of inflammation-related genes in peritoneal tissues compared to the standard IPP and/or CD gas. The odds ratios of a visual analogue scale (VAS) pain score >30 in the ward was 0.18 (95% CI: 0.06, 0.52) at 12?hours and 0.06 (95% CI: 0.01, 0.26) at 24?hours in the low IPP group versus the standard IPP group, and 0.16 (95% CI: 0.05, 0.49) at 0?hours and 0.29 (95% CI: 0.10, 0.79) at 12?hours in the WH gas group versus the CD gas group.

SUBMITTER: Matsuzaki S

PROVIDER: S-EPMC5595842 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Effects of low intraperitoneal pressure and a warmed, humidified carbon dioxide gas in laparoscopic surgery: a randomized clinical trial.

Matsuzaki Sachiko S Vernis Lise L Bonnin Martine M Houlle Celine C Fournet-Fayard Aurelie A Rosano Giuseppe G Lafaye Anne Laure AL Chartier Christian C Barriere Agnes A Storme Brigitte B Bazin Jean-Etienne JE Canis Michel M Botchorishvili Revaz R

Scientific reports 20170912 1

Laparoscopic surgery technology continues to advance. However, much less attention has been focused on how alteration of the laparoscopic surgical environment might improve clinical outcomes. We conducted a randomized, 2 × 2 factorial trial to evaluate whether low intraperitoneal pressure (IPP) (8 mmHg) and/or warmed, humidified CO<sub>2</sub> (WH) gas are better for minimizing the adverse impact of a CO<sub>2</sub> pneumoperitoneum on the peritoneal environment during laparoscopic surgery and f ...[more]

PMID: 28900123

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Project description:BACKGROUND:The aim of this study was to monitor the effect of humidified-warm carbon dioxide (HWCO2 ) delivered into the open abdomen of mice, simulating laparotomy. METHODS:Mice were anaesthetized, ventilated and subjected to an abdominal incision followed by wound retraction. In the experimental group, a diffuser device was used to deliver HWCO2 ; the control group was exposed to passive air flow. In each group of mice, surgical damage was produced on one side of the peritoneal wall. Vital signs and core temperature were monitored throughout the 1-h procedure. The peritoneum was closed and mice were allowed to recover for 24 h or 10 days. Tumour cells were delivered into half of the mice in each cohort. Tissue was then examined using scanning electron microscopy and immunohistochemistry. RESULTS:Passive air flow generated ultrastructural damage including mesothelial cell bulging/retraction and loss of microvilli, as assessed at 24 h. Evidence of surgical damage was still measurable on day 10. HWCO2 maintained normothermia, whereas open surgery alone led to hypothermia. The degree of tissue damage was significantly reduced by HWCO2 compared with that in controls. Peritoneal expression of hypoxia inducible factor 1α and vascular endothelial growth factor A was lowered by HWCO2 . These effects were also evident at the surgical damage sites, where protection from tissue trauma extended to 10 days. HWCO2 did not reduce tumorigenesis in surgically damaged sites compared with passive air flow. CONCLUSION:HWCO2 diffusion into the abdomen in the context of open surgery afforded tissue protection and accelerated tissue repair in mice, while preserving normothermia. Surgical relevance Damage to the peritoneum always occurs during open abdominal surgery, by exposure to desiccating air and by mechanical trauma/damage owing to the surgical intervention. Previous experimental studies showed that humidified-warm carbon dioxide (HWCO2 ) reduced peritoneal damage during laparoscopic insufflation. Additionally, this intervention decreased experimental peritoneal carcinomatosis compared with the use of conventional dry-cold carbon dioxide. In the present experimental study, the simple delivery of HWCO2 into the open abdomen reduced the amount of cellular damage and inflammation, and accelerated tissue repair. Sites of surgical intervention serve as ideal locations for cancer cell adhesion and subsequent tumour formation, but this was not changed measurably by the delivery of HWCO2 .

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

Effects of low intraperitoneal pressure and a warmed, humidified carbon dioxide gas in laparoscopic surgery: a randomized clinical trial.

Publications

Effects of low intraperitoneal pressure and a warmed, humidified carbon dioxide gas in laparoscopic surgery: a randomized clinical trial.

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