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The Effect of Surgical Humidification in Colorectal Cancer Surgery: a Randomised Controlled Trial

ABSTRACT: 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

DISEASE(S): Surgery-surgical Techniques,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2473367 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum. WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen. In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed. Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients’ higher willingness to repeat the procedure. Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI. In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.

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The Effect of Surgical Humidification in Colorectal Cancer Surgery: a Randomised Controlled Trial

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