Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prevention of inadvertent perioperative hypothermia
研究概览
简要总结
There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.
详细描述
Objective
This study was conducted to examine the effect of inadvertent perioperative hypothermia (IPH) on Surgical Site Infection (SSI) in patients undergoing laparoscopic cholecystectomy.
Summary of Background Data: There are conflicting results in the literature explaining the relationship between SSI and IPH. Although the risk of IPH is thought to be lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts about the existence of a relationship between IPH and SSI in laparoscopic surgery patients.
Methods: This study will be a quasi-experimental and randomized controlled study in the future. The study will be conducted with patients who will have undergone laparoscopic cholecystectomy in the general surgery clinic and operating room of a university hospital. The study will be completed with a total of 100 patients, 50 in the case group, and 50 in the control group. During the study, preoperative, intraoperative, and postoperative body temperatures, as well as biomarkers of the patients, will be monitored using a form developed by the researchers. Additionally, patients will be followed up postoperatively to evaluate the potential impact of IPH on SSI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being aged 18-65 years old,
- •Having an ASA score of I-II,
- •Remaining in the hospital for at least 24 hours in the postoperative period,
- •Undergoing laparoscopic cholecystectomy
排除标准
- •Being under 18 or over 65,
- •Having an ASA score above III,
- •Requiring emergency surgery
- •Having a neurological, psychiatric, or neuromuscular disease,
- •Being addicted to alcohol and/or other toxic substances,
- •Being pregnant or having a suspected pregnancy,
- •Undergoing open surgery, or being converted to an open procedure during surgery,
- •Having symptoms of fever
- •Having an active infection excluding cholecystitis.
结局指标
主要结局
Prevention of inadvertent perioperative hypothermia
时间窗: September 15, 2022- September 15, 2023
This study aims to evaluate whether inadvertent perioperative hypothermia has an effect on surgical site infection. For this, applications to prevent hypothermia will be applied to the patients in the experimental group
次要结局
- Following surgical site infection(16 September 16, 2023 - October 25, 2023)
研究者
Pınar YILMAZ EKER
Asst. Prof
Cumhuriyet University