Trial Outcomes & Findings for The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter (NCT NCT06180122)

Results Overview

The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline

Results posted on

2025-09-03

Participant Flow

Recruited from Vascular Outpatients clinic at Charing Cross Hospital between March 2024 and May 2024.

Questionnaire used to obtain a medical history taken from patient on morning of ultrasound scan, to determine which study group the participant should be allocated to (symptomatic or asymptomatic).

Participant milestones

Participant milestones
Measure	Symptomatic Group Participants who suffer from unexplained left leg swelling.	Asymptomatic Group Participants who do not suffer from unexplained left leg swelling
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symptomatic Group n=20 Participants Participants who suffer from unexplained left leg swelling.	Asymptomatic Group n=20 Participants Participants who do not suffer from unexplained left leg swelling	Total n=40 Participants Total of all reporting groups
Age, Continuous	52 Years n=5 Participants	56 Years n=7 Participants	54 Years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	29 kg/m^2 n=5 Participants	25 kg/m^2 n=7 Participants	27 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Data could not be obtained from one participant in the symptomatic group due to non-visualization of the common iliac vein

The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.

Outcome measures

Outcome measures
Measure	Symptomatic Group n=19 Participants Participants who suffer from unexplained left leg swelling.	Asymptomatic Group n=20 Participants Participants who do not suffer from unexplained left leg swelling
Left Common Iliac Vein Diameter	7.5 Millimeters (mm) Standard Deviation 2.9	7.7 Millimeters (mm) Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline

The inter- and intra-operator variation of the diameter measurement of the left common iliac vein using duplex ultrasound, in adults referred to the vascular ultrasound department. Three different scientists took three measurements each of the common iliac vein. The results from the three scientists were compared to determine inter-operator variation, and the results from one scientist each were compared to determine intra-operator variation.

Outcome measures

Outcome measures
Measure	Symptomatic Group n=39 Participants Participants who suffer from unexplained left leg swelling.	Asymptomatic Group n=39 Participants Participants who do not suffer from unexplained left leg swelling
Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein	0.67 ICC - Reliability/descriptive statistic Interval 0.6 to 0.72	0.92 ICC - Reliability/descriptive statistic Interval 0.9 to 0.93

Adverse Events

Symptomatic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asymptomatic 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

Sophie Connolly

Imperial College Healthcare NHS Trust

Phone: 02033117322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place