Intraoperative Radiographic Detection of Retained Surgical Sponges

Not Applicable

• Conditions: Surgical Sponge, Retained

• Registration Number: NCT04097678
• Lead Sponsor: Twin Cities Spine Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2020-11-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy	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	Intraoperative	Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
Intraobserver Reproducibility	Intraoperative	Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
Sensitivity	Intraoperative	Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
Specificity	Intraoperative	Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present

Trial Locations

Locations (1)

Twin Cities Spine Center; 🇺🇸 Minneapolis, Minnesota, United States