Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools Clinical Trial
Official title:
Incidence of a Retained Surgical Device in Patients That Underwent Surgery
| Verified date | March 2020 |
| Source | Assuta Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | September 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment. Exclusion Criteria: - No exclusion criteria |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assuta MC | Tel Aviv | |
| Israel | ASSUTAMC | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Assuta Medical Center |
Israel,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of retained devices | Cases with retained devices or almost accident will be considered | three years | |
| Secondary | Type of devices | Sponge , instruments and others devices | 3 years |