Intraoperative Radiographic Detection of Retained Surgical Sponges
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Retained Sponge Group 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
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.
|
| No Intervention: No Retained Sponge Group No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views). |
Outcome Measures
Primary Outcome Measures
- Correct answers (number) [Intraoperative]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing open posterior instrumented lumbar spine surgery.
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Read and understand English.
Exclusion Criteria:
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Pregnancy.
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Patients who do not consent to research.
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Patients less than 18 years old at the time of consent.
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Do not read and understand English.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Twin Cities Spine Center | Minneapolis | Minnesota | United States | 55404 |
Sponsors and Collaborators
- Twin Cities Spine Center
- Allina Health System
Investigators
- Principal Investigator: Amir A Mehbod, MD, Twin Cities Spine Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008 Jul;207(1):80-7. doi: 10.1016/j.jamcollsurg.2007.12.047. Epub 2008 May 23.
- Hellbach K, Beller E, Schindler A, Schoeppe F, Hesse N, Baumann A, Schinner R, Auweter S, Hauke C, Radicke M, Meinel FG. Improved Detection of Foreign Bodies on Radiographs Using X-ray Dark-Field and Phase-Contrast Imaging. Invest Radiol. 2018 Jun;53(6):352-356. doi: 10.1097/RLI.0000000000000450.
- Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. Review. Erratum in: Emerg Med J. 2004 Jan;21(1):126.
- Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res. 2007 Apr;138(2):170-4. Epub 2007 Feb 1.
- Revesz G, Siddiqi TS, Buchheit WA, Bonitatibus M. Detection of retained surgical sponges. Radiology. 1983 Nov;149(2):411-3.
- Turgut M, Akhaddar A, Turgut AT. Retention of Nonabsorbable Hemostatic Materials (Retained Surgical Sponge, Gossypiboma, Textiloma, Gauzoma, Muslinoma) After Spinal Surgery: A Systematic Review of Cases Reported During the Last Half-Century. World Neurosurg. 2018 Aug;116:255-267. doi: 10.1016/j.wneu.2018.05.119. Epub 2018 May 26. Review.
- Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
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