Transvaginal Pelvic Ultrasound in the ED

Abdominal Pain Clinical Trial

Official title:

Transvaginal Pelvic Ultrasound in the ED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547857
• Other study ID #: HSR 14-3918
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: December 23, 2016
• Start date: September 2015

Study information

• Verified date: December 2016
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology, though its use has not been described in the medical literature. This observational study aims to describe its use in clinical ED practice.

Description:

Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology. During the pelvic examination a transvaginal ultrasound probe is used to visualize ovarian size, determine echotexture, assess whether ovarian tenderness is present, and sometimes measure ovarian blood flow. Though pelvic ultrasound is used in the Hennepin County Medical Center ED routinely, there is a paucity of literature assessing it's utility.

This observational study will help determine the usefulness of this imaging modality, and how often it changes management in clinical practice.

Specifically, this study will attempt to determine how often transvaginal ultrasound identifies the structures of interest, and then will correlate these findings with the final ED diagnosis. If a formal ultrasound is obtained, the findings of the ED ultrasound will also be compared to the findings of the formal ultrasound.

The treating physicians will be queried the diagnosis and management plans before and after the pelvic US to ascertain changes in management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years old female

• ED bedside transvaginal ultrasound to be performed in a non-pregnant woman with at least one ovary

• Willing to discuss how they are doing at 7-10 days via phone

• Valid phone number

Exclusion Criteria:

• If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound

• Previously enrolled in this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Pain
• Pelvic Pain

Intervention

Other:
• Pelvic US
To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Method of finding ovaries	Will choose from: Adjacent to pelvic vessels; Followed out from uterine cornu; No particular method used	8 hours (or less, this will measure what occurs during an ED stay)	No
Other	Experience of sonographer	Choose from: G1; G2; G3-G5; Physician Assistant (PA); Attending; US tech	8 hours (or less, this will measure what occurs during an ED stay)	No
Other	Pelvic physical exam characteristics	Was there tenderness on the exam (right/left adnexa, suprapubic region, no tenderness)? Were any masses felt? (right/left adnexa, suprapubic, no mass)	8 hours (or less, this will measure what occurs during an ED stay)	No
Primary	Change in diagnosis before/after pelvic US	The treating physician will be queried the likelihood of EMERGENT and NON-EMERGENT ovarian pathology before and after pelvic US using the following scale: Definite, Probable, Possible, Very Unlikely. The ED tests reviewed before each of these judgements will be noted. EMERGENT is defined as ovarian torsion or tubo-ovarian abscess (TOA). NON-EMERGENT is defined as all other causes, including ovarian cyst, ovarian mass, ovarian malignancy, adnexal mass). The clinician will also free text the most likely diagnosis. A change of two or more levels (eg definite to possible, definite to very unlikely, probable to very unlikely, or vice versa) will be assumed to be a significant change in diagnosis.	8 hours (or less, this will measure what occurs during an ED stay)	No
Primary	Change in management plan before/after pelvic US	The treating physician will choose from the following regarding the management plan before/after the pelvic US: outpatient referral to OB/GYN, formal pelvic US after bedside US, consult GYN in the ED, urgent/emergent operative intervention, None of the above. Any difference in management before/after pelvic US will be considered a significant change in management.	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Sonographic visualization of ovaries	yes/no	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Duration of pelvic US	Less than 5 minutes, 5-10 minutes, more than 10 minutes	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Ovary enlargement	Were the ovaries larger than 3.5 x 2 cm in any plane? yes/no answer	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Ovarian tenderness, sonographic	As a dichotomous yes/no. This will be correlated to final diagnosis. How many women with a non-tender ovary ended up with EMERGENT pathology? How many had NON-EMERGENT pathology?	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Ovarian blood flow	The physician will determine if the ovarian flow is normal in a dichotomous yes/no answer. (if performed)	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	ED disposition after visit	This will measure if the patient is discharged from the ED or admitted to the hospital	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Final ED diagnosis	Two questions will be answered: Ovarian Pathology, Emergency (tubo-ovarian abscess, torsion); Ovarian Pathology, Non-Emergency (cyst, mass, malignancy); Non-ovarian problem; Question 2: Final ED diagnosis after all work-up: (select all that apply) checkbox; ed_final_dx_2___1 ovarian cyst; ed_final_dx_2___2 ovarian mass; ed_final_dx_2___3 ovarian torsion; ed_final_dx_2___4 tubo-ovarian abscess; ed_final_dx_2___5 other ovarian pathology; ed_final_dx_2___6 adnexal mass (non-ovarian); ed_final_dx_2___7 Pelvic Inflammatory Disease; ed_final_dx_2___8 Abdominal pathology (appendicitis, diverticulitis, SBO, others); ed_final_dx_2___9 Non-specific abdominal pain; ed_final_dx_2___10 None of the above and no ovarian pathology suspected	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	7-day follow-up	Whether another facility was visited, whether a procedure occurred, and what else happened during this stay. Patients will be attempted to be contacted three times.	7 days	No
Secondary	Correlation between ED US and Formal US	If a formal US is obtained, the reading will be abstracted and compared to the ED US for the following: ovary visualization, ovary size, ovarian flow, final diagnosis, and any other abnormality in free text.	8 hours (or less, this will measure what occurs during an ED stay)	Yes
Secondary	Final impression for ED ultrasound with regards to ovaries	NORMAL or ABNORMAL. If abnormal, the abnormality will be described.	8 hours (or less, this will measure what occurs during an ED stay)	No
Secondary	Formal pelvic US	Was this study obtained? dichotomous yes/no. And why was a formal pelvic US obtained? (abnormality of ovaries on bedside US; other abnormality on bedside US; unable to visualize ovaries on bedside US; good visualization of all structures and all structures normal, but post-test probability still high; Other (free text). )The exact reason will then be listed in free text.	8 hours (or less, this will measure what occurs during an ED stay)	No