An observational study in Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools, sponsored by Assuta Medical Center. Completed at 2 sites in Israel. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Assuta Medical Center · Observational
It has been estimated that in the United States alone 48 million operations are performed annually and most involve the use of multiple surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments1. Textile material and instruments forgotten in a patient undergoing an invasive procedure is a negligence of an entire team responsible for maintaining patient safety. A retained surgical foreign body (RSFB) usually requires at least a second surgery for retrieval of the object, and also carries a risk for major complications including morbidity and death2. Retained foreign bodies are underreported to minimize exposure to possible litigation3. Therefore, the real occurrence of RSFB is underestimated, recently there has reported an incidence of 0.356 / 1,000 patients whereas others reported a rate of 1/5000 with an associated mortality ranging from 11 to 35% 4-5.
Therefore, there is a need for improved systems and methods for identifying and tracking surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments during a surgical procedure.
All cases investigated due to retained material during hospital surgical treatment will be included. Incidence, type of procedure performed, the prevalence and guilty of the personal actuating will be considered.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 148 is below the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Assuta Medical Center is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who were admitted to carrying out an intervention in which material used for their treatment was forgotten or almost.
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Exclusion Criteria:
Patients with a retained device or almost
Also known as: retained devices
Incidence of retained devices
Cases with retained devices or almost accident will be considered
Time frame: three years
Type of devices
Sponge , instruments and others devices
Time frame: 3 years
Ran from Jan 2016 to primary completion in Sep 2019, 44 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Assuta Medical Center