Intraoperative Radiographic Detection of Retained Surgical Sponges

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intraoperative Radiographic Detection of Retained Surgical Sponges

Conditions
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Surgical Sponge, Retained

Intervention / Treatment
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* Other: Retained Surgical Sponge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing open posterior instrumented lumbar spine surgery. Read and understand English. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, randomized study with two cohorts: one experimental and one control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retained Sponge Group<br>Just prior to imaging, the surgeon will purposely place a sponge in the wound. Two radiographs will be taken of the spine (AP and Lateral views). | Other: Retained Surgical Sponge<br>* A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge.<br>|
| No Intervention: No Retained Sponge Group<br>No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct answers (number) | Each subject's AP and LAT images will be viewed and the investigator will note whether or not a sponge is seen (graded present or graded absent). The investigator's answer will be compared to the true condition (actually present or actually absent). Results will be analyzed to quantify the relative specificity, sensitivity, positive and negative predictive values, and accuracy of 1) an AP image alone, 2) a LAT image alone, and 3) AP and LAT images together. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar spine surgery, radiographic imaging