NCT04293536

Incidence of Retained Surgical Devices and Treatment

Completed Last updated 9 March 2020

What this trial tests

trial testing Cases study in Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools in 148 participants. Completed in 31 December 2019.

Timeline

1 January 2016

Primary endpoint
30 September 2019

31 December 2019

Quick facts

Lead sponsor	Assuta Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	148
Start date	1 January 2016
Primary completion	30 September 2019
Estimated completion	31 December 2019
Sites	2 locations across Israel

Drugs / interventions tested

• Cases study

Conditions studied

• Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools — all drugs for Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools →

Sponsor

Assuta Medical Center

Who can join

Eligibility, any sex, with Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Addressing the important error of missing surgical items in an operated patient.
   Susmallian S, Barnea R, Azaria B, Szyper-Kravitz M. · · 2022 · cited 2× · PMID 35382877 · DOI 10.1186/s13584-022-00530-z
2. Assessing the diagnostic value of radiographs for retained surgical items: a cautionary analysis.
   Susmallian S, Folv E, Szyper-Kravitz M. · · 2026 · PMID 41143897 · DOI 10.1093/bjr/tqaf241
3. Diagnostic imaging to locate elements lost during the development of a surgery: A cohort study.
   Susmallian S, Szyper-Kravitz M, Folv E, Barnea R. · · 2023 · DOI 10.21203/rs.3.rs-2550581/v1