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Intraoperative Radiographic Detection of Retained Surgical Sponges

NCT04097678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Surgical Sponge, Retained

Interventions

OTHER

Retained Surgical Sponge

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.

Sponsors & Collaborators

  • Allina Health System

    collaborator OTHER

  • Twin Cities Spine Center

    lead OTHER

Principal Investigators

  • Amir A Mehbod, MD · Twin Cities Spine Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04097678 on ClinicalTrials.gov