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Incidence of Retained Surgical Devices and Treatment

NCT04293536 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2020-03-09

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Cases study

Patients with a retained device or almost

Sponsors & Collaborators

  • Assuta Medical Center

    lead OTHER

Principal Investigators

  • Sergio Susmallian, MD · Assuta Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2019-09-30
Completion
2019-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293536 on ClinicalTrials.gov