NCT04293536

Incidence of Retained Surgical Devices and Treatment

Incidence of a Retained Surgical Device in Patients That Underwent Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: Assuta Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Cases study	Patients with a retained device or almost

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-09-30
• Completion: 2019-12-31
• First posted: 2020-03-03
• Last updated: 2020-03-09

Locations

2 sites across 1 country: Israel