Intraoperative Radiographic Detection of Retained Surgical Sponges

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04097678

Enrollment

146

Registered

2019-09-20

Start date

2020-11-10

Completion date

2021-12-08

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Sponge, Retained

Keywords

lumbar spine surgery, radiographic imaging

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.

Interventions

OTHERRetained 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, 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.

Intervention model description

This is a prospective, randomized study with two cohorts: one experimental and one control.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy	Intraoperative	Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together.
Interobserver Reproducibility	Intraoperative	Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
Intraobserver Reproducibility	Intraoperative	Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
Sensitivity	Intraoperative	Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
Specificity	Intraoperative	Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present

Countries

United States

Participant flow

Participants by arm

Arm	Count
Retained Sponge Group 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.	56
No Retained Sponge Group No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).	55
Total	111

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	No Radiographs Obtained During Surgery	17	18

Baseline characteristics

Characteristic	Retained Sponge Group	No Retained Sponge Group	Total
Age, Continuous	63.2 years STANDARD_DEVIATION 11.2	63.4 years STANDARD_DEVIATION 11.3	63.3 years STANDARD_DEVIATION 11.3
Body Mass Index	30.4 kg/m^2	29.4 kg/m^2	30.0 kg/m^2
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	24 Participants	26 Participants	50 Participants
Sex: Female, Male Male	32 Participants	29 Participants	61 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 56	0 / 55
other Total, other adverse events	0 / 56	0 / 55
serious Total, serious adverse events	0 / 56	0 / 55

Arm	Measure	Value (NUMBER)
Lateral Image Alone	Specificity	95 percentage of correct interpretations
Anteroposterior Image Alone	Specificity	88 percentage of correct interpretations
Lateral and Anteroposterior Images Together	Specificity	93 percentage of correct interpretations

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026