Incidence of Retained Surgical Devices and Treatment

Assuta Medical Center

Status

Completed

Conditions

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

Treatments

Other: Cases study

Study type

Observational

Funder types

Other

Identifiers

NCT04293536

AMC 1-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria