Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Inflammatory cytokine level in the peritoneal biopsy samples
研究概览
简要总结
The operating theatre is deliberately made to be cold and dry to prevent bacteria from growing. The problem with this is that during open abdominal surgery, the intestine and the overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum from drying by applying warmed saline packs periodically to the bowel. However, this is not always possible. Sometimes, the surgeon has to perform an important component of the procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries. When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel obstruction. This vicious cycle is repeated when the patient undergoes repetitive open abdominal operations.
This study aimed to be the first human study to:
- Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is increased for pro-inflammatory cytokines. This study also aim to show that proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using Western Blotting) are elevated during the course of the operation.
- Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to the bowel/peritoneum drying (dessication).
This study will attempt to prove this by using humidified, warmed carbon dioxide gas which will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the peritoneal injury and the inflammation. The investigators will attain peritoneal samples during open colorectal operations. The investigators will obtain samples at the beginning and end of the operation. This study design is a randomized controlled trial, where half the patients will receive humidified, warmed carbon dioxide gas during surgery, and the other half will get standard open surgery without carbon dioxide. 40 patients will be recruited in this study. Half (20) will get CO2, and other half (20) will get standard open surgery.
详细描述
Forty patients undergoing open colorectal surgery will be recruited in this randomized controlled trial.
The study 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. This medical grade CO2 will be warmed to 37°C and humidified to 98% RH using humidification system. The sterility of the system will be assessed regularly as per protocol.
The control group will receive no gas insufflation into the open laparotomy wound. This is current standard practice for all patients undergoing open laparotomy for colorectal resection.
The device that will be used for insufflation of sterile, humidified, warmed CO2 is the Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand).
It consists of a bacterial filter and a humidification chamber filed with 180mL sterile water, positioned on 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. The warm and humidified CO2 enters a gas diffuser (ST300DF VITA-diffuserTM, Cardia Innovation AB, Stockholm, Sweden) consisting of a 25cm-long polyvinylchloride tube (inner diameter of 2.5mm) with polyurethane foam at its end. The cylindrical polyurethane foam tip diverts the gas jet in multiple directions via the many small paths inside the foam. The gas is thus uniformly distributed and the large diffuser surface area greatly reduces the velocity of the outflow. Thus the system delivers humidified CO2 at 100% relative humidity and 37C to the surgical wound. The gas diffuser will be positioned inside the open abdominal wound cavity (in the right cranial quadrant) 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 abdominal wall is commenced to be closed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults above age
- •Elective patients.
- •Pathologies: colorectal carcinoma, polyposis syndromes, diverticular diseases, prolapses, and patients with inflammatory bowel disease undergoing elective resection.
- •For colorectal carcinoma, all patients whether they are having curative or palliative surgery will be included.
- •Patients undergoing open elective colectomy, with or without stoma formation/ bowel anastomosis.
排除标准
- •Patients undergoing acute surgery (emergency surgery).
- •Patients undergoing Laparoscopic colectomy (multiport, single incision and also hand assisted) as all these patients receive heated humidified CO
- •For COPD patients, the exclusion criteria would be patients: (1) On home oxygen, (2) Type 2 respiratory failure (CO2 retainers) (3) FEV1<1L, or FEV1/FVC <50% of predicted
结局指标
主要结局
Change in Inflammatory cytokine level in the peritoneal biopsy samples
时间窗: At the moment of time when: (1) peritoneal cavity is being opened, (2) when peritoneal cavity is being closed (expected average of 2 hours after peritoneal cavity is first opened)
Peritoneal samples will be taken when the peritoneal cavity is being opened (at beginning of operation), and also when the peritoneal cavity is being closed (at end of the operation). The change in the level of inflammatory cytokines in between these two time points will be measured
Intraoperative temperature at 60 minutes from start of operation
时间窗: 60 minutes from start of operation
Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
Intraoperative temperature at 30 minutes from start of operation
时间窗: 30 minutes from start of operation
Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
次要结局
- Anastomotic leaks(6 months)
- Postoperative Analgesia requirement for pain(Time from when the patient is moved out of operating theater to when the patient is no longer an inpatient in the hospital ward (discharged), with an expected average of 1 week)
- Length of in-patient hospital stay(duration of hospital stay, an expected average of 1 week)
研究者
Dr Ju Yong Cheong
Doctor
Concord Repatriation General Hospital