Intraoperative Radiographic Detection of Retained Surgical Sponges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Accuracy
研究概览
简要总结
This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography. The purpose is to find out how useful plain x-rays are in open posterior lumbar spine surgery, information which is presently unavailable. The specific aim is to compare the sensitivity (seeing a sponge when one is actually present) and specificity (not seeing a sponge when one is not present) of radiography of the surgical field for three conditions: viewing one lateral radiograph versus viewing one anteroposterior radiograph versus viewing two radiographs together, one lateral and one anteroposterior.
详细描述
This is a prospective, randomized study with two cohorts: one experimental and one control. Anteroposterior (AP) and lateral (LAT) radiographs are routinely obtained as standard of care during spine surgery to confirm proper implant placement. These images will be used in this study. In one-half of the study subjects, after all sponges are removed, a surgical sponge will be intentionally placed in the surgical field prior to imaging. Postoperatively, each subject's images will be assessed for the presence or absence of a retained surgical sponge. Images will be independently read by two investigators. When there is discordance, the images will be adjudicated by a third. Interobserver agreement will be quantified using the Kappa statistic. Those reading images will not have participated in the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a semi-blinded trial. Investigators performing the surgery will know whether or not a sponge is present but the investigators reviewing the images will not. Subjects will not be told which study group they are in.
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
- •Patients undergoing open posterior instrumented lumbar spine surgery.
- •Read and understand English.
排除标准
- •Pregnancy.
- •Patients who do not consent to research.
- •Patients less than 18 years old at the time of consent.
- •Do not read and understand English.
结局指标
主要结局
Accuracy
时间窗: Intraoperative
Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together.
Interobserver Reproducibility
时间窗: Intraoperative
Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
Intraobserver Reproducibility
时间窗: Intraoperative
Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
Sensitivity
时间窗: Intraoperative
Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
Specificity
时间窗: Intraoperative
Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present
次要结局
未报告次要终点