Intraoperative Radiographic Detection of Retained Surgical Sponges
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|ClinicalTrials.gov Identifier: NCT04097678|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Sponge, Retained||Other: Retained Surgical Sponge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a prospective, randomized study with two cohorts: one experimental and one control.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Intraoperative Radiographic Detection of Retained Surgical Sponges|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Retained Sponge Group
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
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.
No Intervention: No Retained Sponge Group
No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
- Correct answers (number) [ Time Frame: Intraoperative ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097678
|Contact: John M Dawson, PhDfirstname.lastname@example.org|
|United States, Minnesota|
|Twin Cities Spine Center||Active, not recruiting|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Amir A Mehbod, MD||Twin Cities Spine Center|