Intraoperative Radiographic Detection of Retained Surgical Sponges

Surgical Sponge, Retained Clinical Trial

Official title:

Intraoperative Radiographic Detection of Retained Surgical Sponges

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04097678
• Other study ID #: 1290533
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: June 2023

Study information

• Verified date: October 2021
• Source: Twin Cities Spine Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 146
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing open posterior instrumented lumbar spine surgery.

• Read and understand English.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Foreign Bodies
• Surgical Sponge, Retained

Intervention

Other:
• Retained Surgical Sponge
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.

Locations

Country	Name	City	State
United States	Twin Cities Spine Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Twin Cities Spine Center	Allina Health System

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. Review. Erratum in: Emerg Med J. 2004 Jan;21(1):126. — View Citation

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. Epub 2007 Feb 1. — View Citation

Revesz G, Siddiqi TS, Buchheit WA, Bonitatibus M. Detection of retained surgical sponges. Radiology. 1983 Nov;149(2):411-3. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct answers (number)	Each subject's AP and LAT images will be viewed and the investigator will note whether or not a sponge is seen (graded present or graded absent). The investigator's answer will be compared to the true condition (actually present or actually absent). Results will be analyzed to quantify the relative specificity, sensitivity, positive and negative predictive values, and accuracy of 1) an AP image alone, 2) a LAT image alone, and 3) AP and LAT images together.	Intraoperative