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OpenTrials
Completed

NCT Number: NCT04293536

Incidence of Retained Surgical Devices and Treatment

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

ASSUTAMC, Tel Aviv, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cases study

Other

Patients with a retained device or almost

Other names: retained devices

Primary outcomes

  1. Incidence of retained devices

    Time frame: three years

    Cases with retained devices or almost accident will be considered

Secondary outcomes

  1. Type of devices

    Time frame: 3 years

    Sponge , instruments and others devices

Sponsors and collaborators

Lead sponsor

Assuta Medical Center

Other

Registry information

Official study title

Incidence of a Retained Surgical Device in Patients That Underwent Surgery

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2020
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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