Intraoperative Radiographic Detection of Retained Surgical Sponges

Twin Cities Spine Center

Status: Completed

Conditions: Surgical Sponge, Retained

Treatments: Other: Retained Surgical Sponge

Study type: Interventional

Funder types: Other

Identifiers

NCT04097678

1290533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups

Retained Sponge Group

Experimental group

Description:

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).

Treatment:

Other: Retained Surgical Sponge

No Retained Sponge Group

No Intervention group

Description:

No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).