Intraoperative Radiographic Detection of Retained Surgical Sponges

NCT04097678 | Completed Results

• 1 other identifier: 1290533
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Sponge, Retained

Keywords

lumbar spine surgery; radiographic imaging

Outcome Measures

Primary Outcomes (5)

• 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.

  Intraoperative

• Interobserver Reproducibility

  Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations

  Intraoperative

• Intraobserver Reproducibility

  Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself

  Intraoperative

• Sensitivity

  Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present

  Intraoperative

• Specificity

  Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present

  Intraoperative

Study Arms (2)

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).

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).

Interventions

Retained Surgical Sponge OTHER

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.

Retained Sponge Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Twin Cities Spine Center: lead
• Allina Health System: collaborator

Study Sites (1)

Twin Cities Spine Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (7)

• 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.

  PMID: 18589366 BACKGROUND

• 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.

  PMID: 17275034 BACKGROUND

• 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.

  PMID: 29807184 BACKGROUND

• Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.

  PMID: 15883903 BACKGROUND

• 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.

  PMID: 6622683 BACKGROUND

• 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.

  PMID: 12954688 BACKGROUND

• 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.

  PMID: 29420322 BACKGROUND

MeSH Terms

Conditions

Foreign Bodies

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Clinical Research Director
• Organization: Twin Cities Spine Center

jmdawson@tcspine.com

612-775-6222

Study Officials

• Amir A Mehbod, MD

  Twin Cities Spine Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a semi-blinded trial. Investigators performing the surgery will know whether or not a sponge is present but the investigators reviewing the images will not. Subjects will not be told which study group they are in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized study with two cohorts: one experimental and one control.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 20, 2019
• Study Start: November 10, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)