Intraoperative Radiographic Detection of Retained Surgical Sponges
NCT ID: NCT04097678
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2020-11-10
2021-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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).
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 Retained Sponge Group
No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Read and understand English.
Exclusion Criteria
* Patients who do not consent to research.
* Patients less than 18 years old at the time of consent.
* Do not read and understand English.
18 Years
ALL
No
Sponsors
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Allina Health System
OTHER
Twin Cities Spine Center
OTHER
Responsible Party
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Principal Investigators
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Amir A Mehbod, MD
Role: PRINCIPAL_INVESTIGATOR
Twin Cities Spine Center
Locations
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Twin Cities Spine Center
Minneapolis, Minnesota, United States
Countries
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References
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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.
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. doi: 10.1016/j.jss.2006.08.001. Epub 2007 Feb 1.
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.
Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
Revesz G, Siddiqi TS, Buchheit WA, Bonitatibus M. Detection of retained surgical sponges. Radiology. 1983 Nov;149(2):411-3. doi: 10.1148/radiology.149.2.6622683.
Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1290533
Identifier Type: -
Identifier Source: org_study_id
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