Incidence of Retained Surgical Devices and Treatment

NCT ID: NCT04293536

Last Updated: 2020-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Cases study

Patients with a retained device or almost

Intervention Type OTHER

Other Intervention Names

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retained devices

Eligibility Criteria

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Inclusion Criteria

* Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assuta Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sergio Gabriel Susmallian

Medicine Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergio Susmallian, MD

Role: PRINCIPAL_INVESTIGATOR

Assuta Medical Center

Locations

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ASSUTAMC

Tel Aviv, , Israel

Site Status

Assuta MC

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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Lauwers PR, Van Hee RH. Intraperitoneal gossypibomas: the need to count sponges. World J Surg. 2000 May;24(5):521-7. doi: 10.1007/s002689910084.

Reference Type BACKGROUND
PMID: 10787070 (View on PubMed)

Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.

Reference Type RESULT
PMID: 28256998 (View on PubMed)

Hariharan D, Lobo DN. Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl. 2013 Mar;95(2):87-92. doi: 10.1308/003588413X13511609957218.

Reference Type RESULT
PMID: 23484986 (View on PubMed)

Berkowitz S, Marshall H, Charles A. Retained intra-abdominal surgical instruments: time to use nascent technology? Am Surg. 2007 Nov;73(11):1083-5.

Reference Type RESULT
PMID: 18092638 (View on PubMed)

Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008 Jul;207(1):80-7. doi: 10.1016/j.jamcollsurg.2007.12.047. Epub 2008 May 23.

Reference Type RESULT
PMID: 18589366 (View on PubMed)

Recommended practices for sponge, sharp, and instrument counts. AORN Recommended Practices Committee. Association of periOperative Registered Nurses. AORN J. 1999 Dec;70(6):1083-9. doi: 10.1016/s0001-2092(06)62224-2. No abstract available.

Reference Type RESULT
PMID: 10635432 (View on PubMed)

Steelman VM, Shaw C, Shine L, Hardy-Fairbanks AJ. Retained surgical sponges: a descriptive study of 319 occurrences and contributing factors from 2012 to 2017. Patient Saf Surg. 2018 Jun 29;12:20. doi: 10.1186/s13037-018-0166-0. eCollection 2018.

Reference Type RESULT
PMID: 29988638 (View on PubMed)

Brooks J. US Medicare will stop paying for preventable errors. CMAJ. 2007 Oct 9;177(8):841-2. doi: 10.1503/cmaj.071347. No abstract available.

Reference Type RESULT
PMID: 17923647 (View on PubMed)

Wan W, Le T, Riskin L, Macario A. Improving safety in the operating room: a systematic literature review of retained surgical sponges. Curr Opin Anaesthesiol. 2009 Apr;22(2):207-14. doi: 10.1097/ACO.0b013e328324f82d.

Reference Type RESULT
PMID: 19390247 (View on PubMed)

Susmallian S, Folv E, Szyper-Kravitz M. Assessing the diagnostic value of radiographs for retained surgical items: a cautionary analysis. Br J Radiol. 2025 Oct 1:tqaf241. doi: 10.1093/bjr/tqaf241. Online ahead of print.

Reference Type DERIVED
PMID: 41143897 (View on PubMed)

Susmallian S, Barnea R, Azaria B, Szyper-Kravitz M. Addressing the important error of missing surgical items in an operated patient. Isr J Health Policy Res. 2022 Apr 5;11(1):19. doi: 10.1186/s13584-022-00530-z.

Reference Type DERIVED
PMID: 35382877 (View on PubMed)

Other Identifiers

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AMC 1-2020

Identifier Type: -

Identifier Source: org_study_id

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