Trial Outcomes & Findings for Uterosacral Ligament Suspension Clip (NCT NCT02700997)

Last Updated: 2018-11-09

Results Overview

Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

1 day after surgery

Results posted on

2018-11-09

Participant milestones
Measure	Vascular Clip Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Vascular Clip Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging
Overall Study Did not undergo CT imaging	1
Overall Study No CT measurement - pelvic calcification	1

Uterosacral Ligament Suspension Clip

Baseline characteristics by cohort
Measure	Vascular Clip n=15 Participants Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	15 Participants n=93 Participants
BMI	28 kg/m^2 n=93 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 14.2 • n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants

Timeframe: 1 day after surgery

Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.

Outcome measures
Measure	Vascular Clip n=15 Participants Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging
Suture Location in Relation to the Surrounding Anatomy Internal iliac complex from right proximal suture	2.5 cm Standard Deviation 0.5
Suture Location in Relation to the Surrounding Anatomy Internal iliac complex from left proximal suture	2.8 cm Standard Deviation 0.7
Suture Location in Relation to the Surrounding Anatomy Right ureter from right proximal suture	2.2 cm Standard Deviation 0.5
Suture Location in Relation to the Surrounding Anatomy Right ureter from right distal suture	2.2 cm Standard Deviation 0.4
Suture Location in Relation to the Surrounding Anatomy Left ureter from left proximal suture	2.4 cm Standard Deviation 0.6
Suture Location in Relation to the Surrounding Anatomy Left ureter from left distal suture	2.5 cm Standard Deviation 0.6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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