NCT04097678

Intraoperative Radiographic Detection of Retained Surgical Sponges

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Twin Cities Spine Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Sponge, Retained

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-12-08
• Completion: 2021-12-08
• First posted: 2019-09-20
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States