Incidence of Retained Surgical Devices and Treatment

Completed

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

• Registration Number: NCT04293536
• Lead Sponsor: Assuta Medical Center

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31
• Study First Submitted: 2020-02-29
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of retained devices	three years	Cases with retained devices or almost accident will be considered

Secondary Outcome Measures

Name	Time	Method
Type of devices	3 years	Sponge , instruments and others devices

Trial Locations

Locations (2)

ASSUTAMC; 🇮🇱 Tel Aviv, Israel

Assuta MC; 🇮🇱 Tel Aviv, Israel