Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical ToolsNCT04293536
Incidence of Retained Surgical Devices and Treatment
An observational study of Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools, run by Assuta Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools
- What is being tested?
- Cases study
- How many people
- 148 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jan 2016to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were admitted to carrying out an intervention in which material used for their treatment was forgotten or almost.
Who may be able to join
- Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment.
Who cannot join
- No exclusion criteria
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Incidence of a Retained Surgical Device in Patients That Underwent Surgery
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.
Read the 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
- Being tested
- Cases study
- Medical subject headings
- Postoperative Complications, Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cases studyOther
Also called retained devices
Patients with a retained device or almost
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of retained devices
Cases with retained devices or almost accident will be considered
Measured: three years
Secondary outcomes (1)
Type of devices
Sponge , instruments and others devices
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jan 2016
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical ToolsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- Sergio Susmallian, MD, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293536
- Sponsor's protocol ID
- AMC 1-2020
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10787070Hall 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.
PubMed 28256998Hariharan D, Lobo DN. Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl. 2013 Mar;95(2):87-92. doi: 10.1308/003588413X13511609957218.
PubMed 23484986Berkowitz S, Marshall H, Charles A. Retained intra-abdominal surgical instruments: time to use nascent technology? Am Surg. 2007 Nov;73(11):1083-5.
PubMed 18092638Cima 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.
PubMed 18589366Recommended 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.
PubMed 10635432Steelman 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.
PubMed 29988638Brooks 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.
PubMed 17923647Wan 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.
PubMed 19390247Susmallian S, Folv E, Szyper-Kravitz M. Assessing the diagnostic value of radiographs for retained surgical items: a cautionary analysis. Br J Radiol. 2026 Jan 1;99(1177):150-156. doi: 10.1093/bjr/tqaf241.
PubMed 41143897Susmallian 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.
PubMed 35382877
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of a Retained Surgical Device in Patients That Underwent Surgery
- ClinicalTrials.gov ID
- NCT04293536
- Acronym / sponsor ID
- AMC 1-2020
- Conditions
- Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were admitted to carrying out an intervention in which material used for their treatment was forgotten or almost.
Key inclusion criteria (1 listed)
- Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cases studyAlso: retained devicesPatients with a retained device or almost | Other | – |
Primary outcome
Incidence of retained devices
Time frame: three years
Cases with retained devices or almost accident will be considered
1 secondary outcome
Type of devices
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Background: PubMed 10787070Lauwers PR, Van Hee RH. Intraperitoneal gossypibomas: the need to count sponges. World J Surg. 2000 May;24(5):521-7. doi: 10.1007/s002689910084.
- Results publication: PubMed 28256998Hall 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.
- Results publication: PubMed 23484986Hariharan D, Lobo DN. Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl. 2013 Mar;95(2):87-92. doi: 10.1308/003588413X13511609957218.
- Results publication: PubMed 18092638Berkowitz S, Marshall H, Charles A. Retained intra-abdominal surgical instruments: time to use nascent technology? Am Surg. 2007 Nov;73(11):1083-5.
- Results publication: PubMed 18589366Cima 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.
- Results publication: PubMed 10635432Recommended 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.
- Results publication: PubMed 29988638Steelman 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.
- Results publication: PubMed 17923647Brooks 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.
- Results publication: PubMed 19390247Wan 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.
- Derived from this study: PubMed 41143897Susmallian S, Folv E, Szyper-Kravitz M. Assessing the diagnostic value of radiographs for retained surgical items: a cautionary analysis. Br J Radiol. 2026 Jan 1;99(1177):150-156. doi: 10.1093/bjr/tqaf241.
- Derived from this study: PubMed 35382877Susmallian 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Susmallian, MD principal investigator
Assuta Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools, run by Assuta Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of retained devices (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293536, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.