N/A
Completed N=146
Intraoperative Radiographic Detection of Retained Surgical Sponges
Surgical Sponge, Retained
Source: ClinicalTrials.gov NCT04097678 ↗
Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Accuracy — 0.76; 0.73; 0.80 Cohen's Kappa
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy |
0.76; 0.73; 0.80 | — |
| PRIMARY Interobserver Reproducibility |
0.89; 0.85; 0.96 | — |
| PRIMARY Intraobserver Reproducibility |
0.91; 0.88; 0.96 | — |
| PRIMARY Sensitivity |
82; 86; 87 | — |
| PRIMARY Specificity |
95; 88; 93 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04097678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.