Clinical trial NCT04097678: Intraoperative Radiographic Detection of Retained Surgical Sponges
Official title: Intraoperative Radiographic Detection of Retained Surgical Sponges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Sponge, Retained
Keywords: lumbar spine surgery
radiographic imaging
Lead sponsor: Twin Cities Spine Center
Sponsor class: OTHER
Collaborators: name: Allina Health System
First posted: 2019-09-20
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized study with two cohorts: one experimental and one control.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy
timeFrame: Intraoperative
measure: Interobserver Reproducibility
timeFrame: Intraoperative
measure: Intraobserver Reproducibility
timeFrame: Intraoperative
measure: Sensitivity
timeFrame: Intraoperative
measure: Specificity
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Twin Cities Spine Center
state: Minnesota
Study officials:
affiliation: Twin Cities Spine Center
name: Amir A Mehbod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.jss.2006.08.001. Epub 2007 Feb 1.
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.
citation: Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
citation: 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.
citation: 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.
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.