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Incidence of Retained Surgical Devices and Treatment

Incidence of a Retained Surgical Device in Patients That Underwent Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04293536
Enrollment
148
Registered
2020-03-03
Start date
2016-01-01
Completion date
2019-12-31
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools

Brief summary

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.

Detailed description

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.

Interventions

OTHERCases study

Patients with a retained device or almost

Sponsors

Assuta Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment.

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Incidence of retained devicesthree yearsCases with retained devices or almost accident will be considered

Secondary

MeasureTime frameDescription
Type of devices3 yearsSponge , instruments and others devices

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026