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Completed

NCT Number: NCT04097678

Intraoperative Radiographic Detection of Retained Surgical Sponges

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.

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Key information

Conditions

Surgical Sponge, Retained Foreign Bodies Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Twin Cities Spine Center

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retained Surgical Sponge

Other

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.

Primary outcomes

  1. Accuracy

    Time frame: 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.

  2. Interobserver Reproducibility

    Time frame: Intraoperative

    Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations

  3. Intraobserver Reproducibility

    Time frame: Intraoperative

    Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself

  4. Sensitivity

    Time frame: Intraoperative

    Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present

  5. Specificity

    Time frame: Intraoperative

    Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present

Sponsors and collaborators

Lead sponsor

Twin Cities Spine Center

Other

Collaborators

  • Allina Health System

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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