Surgical Sponge, RetainedNCT04097678

Intraoperative Radiographic Detection of Retained Surgical Sponges

A study testing Retained Surgical Sponge in people with Surgical Sponge, Retained, run by Twin Cities Spine Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Sponge, Retained
What is being tested?: Retained Surgical Sponge
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 1 siteUnited States
Study dates: 10 Nov 2020to 8 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing open posterior instrumented lumbar spine surgery.
Read and understand English.

Who cannot join

Pregnancy.
Patients who do not consent to research.
Patients less than 18 years old at the time of consent.
Do not read and understand English.

Trial locations and contacts

1 site in 1 country.

United States1 site

Twin Cities Spine Center
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography. The purpose is to find out how useful plain x-rays are in open posterior lumbar spine surgery, information which is presently unavailable. The specific aim is to compare the sensitivity (seeing a sponge when one is actually present) and specificity (not seeing a sponge when one is not present) of radiography of the surgical field for three conditions: viewing one lateral radiograph versus viewing one anteroposterior radiograph versus viewing two radiographs together, one lateral and one anteroposterior.

Read the detailed description

This is a prospective, randomized study with two cohorts: one experimental and one control. Anteroposterior (AP) and lateral (LAT) radiographs are routinely obtained as standard of care during spine surgery to confirm proper implant placement. These images will be used in this study. In one-half of the study subjects, after all sponges are removed, a surgical sponge will be intentionally placed in the surgical field prior to imaging. Postoperatively, each subject's images will be assessed for the presence or absence of a retained surgical sponge. Images will be independently read by two investigators. When there is discordance, the images will be adjudicated by a third. Interobserver agreement will be quantified using the Kappa statistic. Those reading images will not have participated in the surgery.

Conditions: Surgical Sponge, Retained
Being tested: Retained Surgical Sponge
Keywords: lumbar spine surgery, radiographic imaging
Medical subject headings: Foreign Bodies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Retained Surgical SpongeOther
A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge.

Study groups in NCT04097678
Study group	Role	What they receive
Retained Sponge Group	Experimental	Just prior to imaging, the surgeon will purposely place a sponge in the wound. Two radiographs will be taken of the spine (AP and Lateral views). Receives: Other: Retained Surgical Sponge
No Retained Sponge Group	No intervention	No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy
Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together.
Measured: Intraoperative
Interobserver Reproducibility
Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
Measured: Intraoperative
Intraobserver Reproducibility
Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
Measured: Intraoperative
Sensitivity
Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
Measured: Intraoperative
Specificity
Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Nov 20208 Dec 2021

First posted20 Sep 2019
Study start10 Nov 2020
Primary completion8 Dec 2021
Study completion8 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Surgical Sponge, RetainedStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective, randomized study with two cohorts: one experimental and one control.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04097678
Sponsor's protocol ID: 1290533
Status last verified: Oct 2022
First submitted: 19 Sep 2019
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is not a plan to make individual participant data (IPD) available.

Publications

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.
PubMed 18589366
Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res. 2007 Apr;138(2):170-4. doi: 10.1016/j.jss.2006.08.001. Epub 2007 Feb 1.
PubMed 17275034
Turgut M, Akhaddar A, Turgut AT. Retention of Nonabsorbable Hemostatic Materials (Retained Surgical Sponge, Gossypiboma, Textiloma, Gauzoma, Muslinoma) After Spinal Surgery: A Systematic Review of Cases Reported During the Last Half-Century. World Neurosurg. 2018 Aug;116:255-267. doi: 10.1016/j.wneu.2018.05.119. Epub 2018 May 26.
PubMed 29807184
Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
PubMed 15883903
Revesz G, Siddiqi TS, Buchheit WA, Bonitatibus M. Detection of retained surgical sponges. Radiology. 1983 Nov;149(2):411-3. doi: 10.1148/radiology.149.2.6622683.
PubMed 6622683
Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453.
PubMed 12954688
Hellbach K, Beller E, Schindler A, Schoeppe F, Hesse N, Baumann A, Schinner R, Auweter S, Hauke C, Radicke M, Meinel FG. Improved Detection of Foreign Bodies on Radiographs Using X-ray Dark-Field and Phase-Contrast Imaging. Invest Radiol. 2018 Jun;53(6):352-356. doi: 10.1097/RLI.0000000000000450.
PubMed 29420322

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraoperative Radiographic Detection of Retained Surgical Sponges
ClinicalTrials.gov ID: NCT04097678
Acronym / sponsor ID: 1290533
Conditions: Surgical Sponge, Retained
Keywords: lumbar spine surgery, radiographic imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: Twin Cities Spine CenterUniversity, hospital or other
Collaborators: Allina Health System
Study start: 10 Nov 2020 (actual)
Primary completion: 8 Dec 2021 (actual)
Study completion: 8 Dec 2021 (actual)
First posted: 20 Sep 2019 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: This is a prospective, randomized study with two cohorts: one experimental and one control.

Arm	Type	Receives
Retained Sponge Group	Experimental	Other: Retained Surgical SpongeJust prior to imaging, the surgeon will purposely place a sponge in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
No Retained Sponge Group	No intervention	–No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients undergoing open posterior instrumented lumbar spine surgery.
Read and understand English.

Key exclusion criteria (4 listed)

Pregnancy.
Patients who do not consent to research.
Patients less than 18 years old at the time of consent.
Do not read and understand English.

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
Retained Surgical SpongeA surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge.	Other	Retained Sponge Group

Primary outcome

Accuracy
Time frame: Intraoperative
Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together.
Interobserver Reproducibility
Time frame: Intraoperative
Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
Intraobserver Reproducibility
Time frame: Intraoperative
Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
Sensitivity
Time frame: Intraoperative
Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
Specificity
Time frame: Intraoperative
Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Retained Sponge Group	73	56
No Retained Sponge Group	73	55

Primary outcome: Accuracy

Time frame: Intraoperative. Number. Unit: Cohen's Kappa

Measure	Lateral Image Alone n = 111	Anteroposterior Image Alone n = 111	Lateral and Anteroposterior Images Together n = 111
Value	0.76	0.73	0.80

Primary outcome: Interobserver Reproducibility

Time frame: Intraoperative. Number. Unit: Cohen's Kappa

Measure	Lateral Image Alone n = 111	Anteroposterior Image Alone n = 111	Lateral and Anteroposterior Images Together n = 111
Value	0.89	0.85	0.96

Primary outcome: Intraobserver Reproducibility

Time frame: Intraoperative. Number. Unit: Cohen's Kappa

Measure	Lateral Image Alone n = 111	Anteroposterior Image Alone n = 111	Lateral and Anteroposterior Images Together n = 111
Value	0.91	0.88	0.96

Primary outcome: Sensitivity

Time frame: Intraoperative. Number. Unit: percentage of correct interpretations

Measure	Lateral Image Alone n = 111	Anteroposterior Image Alone n = 111	Lateral and Anteroposterior Images Together n = 111
Value	82	86	87

Adverse events

Time frame: Intraoperative. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Retained Sponge Group	0 of 56 (0%)	0 of 56 (0%)	0 of 56
No Retained Sponge Group	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: 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.
Background: PubMed 17275034Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res. 2007 Apr;138(2):170-4. doi: 10.1016/j.jss.2006.08.001. Epub 2007 Feb 1.
Background: PubMed 29807184Turgut M, Akhaddar A, Turgut AT. Retention of Nonabsorbable Hemostatic Materials (Retained Surgical Sponge, Gossypiboma, Textiloma, Gauzoma, Muslinoma) After Spinal Surgery: A Systematic Review of Cases Reported During the Last Half-Century. World Neurosurg. 2018 Aug;116:255-267. doi: 10.1016/j.wneu.2018.05.119. Epub 2018 May 26.
Background: PubMed 15883903Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
Background: PubMed 6622683Revesz G, Siddiqi TS, Buchheit WA, Bonitatibus M. Detection of retained surgical sponges. Radiology. 1983 Nov;149(2):411-3. doi: 10.1148/radiology.149.2.6622683.
Background: PubMed 12954688Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453.
Background: PubMed 29420322Hellbach K, Beller E, Schindler A, Schoeppe F, Hesse N, Baumann A, Schinner R, Auweter S, Hauke C, Radicke M, Meinel FG. Improved Detection of Foreign Bodies on Radiographs Using X-ray Dark-Field and Phase-Contrast Imaging. Invest Radiol. 2018 Jun;53(6):352-356. doi: 10.1097/RLI.0000000000000450.
Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.

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.

Amir A Mehbod, MD principal investigator

Twin Cities Spine Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Retained Surgical Sponge in people with Surgical Sponge, Retained, run by Twin Cities Spine Center at 1 site in United States.

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 2 inclusion and 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy (time frame: Intraoperative). The study lists 5 primary outcomes in all. 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 NCT04097678, which also lists 7 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 19 Sep 2024.