Trial Outcomes & Findings for Intraoperative Radiographic Detection of Retained Surgical Sponges (NCT NCT04097678)

NCT ID: NCT04097678

Last Updated: 2024-09-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	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.	No Retained Sponge Group No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
Overall Study STARTED	73	73
Overall Study COMPLETED	56	55
Overall Study NOT COMPLETED	17	18

Reasons for withdrawal

Measure	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.	No Retained Sponge Group No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
Overall Study No Radiographs Obtained During Surgery	17	18

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Retained Sponge Group n=56 Participants 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 Retained Sponge Group n=55 Participants No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).	Total n=111 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 11.2 • n=56 Participants	63.4 years STANDARD_DEVIATION 11.3 • n=55 Participants	63.3 years STANDARD_DEVIATION 11.3 • n=111 Participants
Sex: Female, Male Female	24 Participants n=56 Participants	26 Participants n=55 Participants	50 Participants n=111 Participants
Sex: Female, Male Male	32 Participants n=56 Participants	29 Participants n=55 Participants	61 Participants n=111 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index	30.4 kg/m^2 n=56 Participants	29.4 kg/m^2 n=55 Participants	30.0 kg/m^2 n=111 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Lateral Image Alone n=111 Images Lateral x-ray of surgical field viewed alone	Anteroposterior Image Alone n=111 Images Anteroposterior x-ray of surgical field viewed alone	Lateral and Anteroposterior Images Together n=111 Images Lateral and Anteroposterior x-rays of surgical field view together
Accuracy	0.76 Cohen's Kappa	0.73 Cohen's Kappa	0.80 Cohen's Kappa

PRIMARY outcome

Timeframe: Intraoperative

Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations

Outcome measures

Measure	Lateral Image Alone n=111 Images Lateral x-ray of surgical field viewed alone	Anteroposterior Image Alone n=111 Images Anteroposterior x-ray of surgical field viewed alone	Lateral and Anteroposterior Images Together n=111 Images Lateral and Anteroposterior x-rays of surgical field view together
Interobserver Reproducibility	0.89 Cohen's Kappa	0.85 Cohen's Kappa	0.96 Cohen's Kappa

PRIMARY outcome

Timeframe: Intraoperative

Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself

Outcome measures

Measure	Lateral Image Alone n=111 Images Lateral x-ray of surgical field viewed alone	Anteroposterior Image Alone n=111 Images Anteroposterior x-ray of surgical field viewed alone	Lateral and Anteroposterior Images Together n=111 Images Lateral and Anteroposterior x-rays of surgical field view together
Intraobserver Reproducibility	0.91 Cohen's Kappa	0.88 Cohen's Kappa	0.96 Cohen's Kappa

PRIMARY outcome

Timeframe: Intraoperative

Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present

Outcome measures

Measure	Lateral Image Alone n=111 Images Lateral x-ray of surgical field viewed alone	Anteroposterior Image Alone n=111 Images Anteroposterior x-ray of surgical field viewed alone	Lateral and Anteroposterior Images Together n=111 Images Lateral and Anteroposterior x-rays of surgical field view together
Sensitivity	82 percentage of correct interpretations	86 percentage of correct interpretations	87 percentage of correct interpretations

PRIMARY outcome

Timeframe: Intraoperative

Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present

Outcome measures

Measure	Lateral Image Alone n=111 Images Lateral x-ray of surgical field viewed alone	Anteroposterior Image Alone n=111 Images Anteroposterior x-ray of surgical field viewed alone	Lateral and Anteroposterior Images Together n=111 Images Lateral and Anteroposterior x-rays of surgical field view together
Specificity	95 percentage of correct interpretations	88 percentage of correct interpretations	93 percentage of correct interpretations

Adverse Events

Retained Sponge Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Retained Sponge Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Director

Twin Cities Spine Center

Phone: 612-775-6222

Email: jmdawson@tcspine.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place