Ureteral Patency After Uterosacral Ligaments Suspension

NCT05477043 | Unknown

• 1 other identifier: US-URETERS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach. USLS is associated with favorable outcomes and is overall safe. However, given the anatomical proximity of the uterosacral ligaments to the ureters, ureteral injury during suspension suture placement may occur. Ureteral occlusion in this setting occurs as a result of partial or complete ligation, kinking or anatomical distortion by the nearby sutures. As a measure for avoiding these undesired sequelae, cystoscopy is usually performed after suspension suture placement during USLS to ensure visualization of bilateral ureteral flow. Any interruption of ureteral flow is usually addressed by removal of the suspension sutures, ureteral stenting, and, rarely, surgical repair of the ureter if severe injury is sustained. Ultrasound can identify the ureteral jet of urine flowing into the bladder. Previous studies demonstrated ureteral jet asymmetry in case of obstruction, with an absent or weaker monolateral jet.

Conditions

Uterovaginal Prolapse; Ureteral Injury; Surgery--Complications

Keywords

Uterovaginal prolapse; uterosacral ligament suspension; ureteral patency; ultrasound

Outcome Measures

Primary Outcomes (1)

• Detection of ureteral patency

  ultrasound detection of the bilateral ureteral jets vs absence of the ureteral jet on one side compared with the presence of bilateral ureteral jet on cystoscopy vs absence on one side.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Duration

  through study completion, an average of 1 year

Study Arms (1)

group of study

Patients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse.

Diagnostic Test: Transabdominal ultrasound and cistoscopy

Interventions

Transabdominal ultrasound and cistoscopy DIAGNOSTIC_TEST

Ultrasound detection of the bilateral ureteral jets vs absence of the ureteral jet on one side compared with the presence of bilateral ureteral jet on cystoscopy vs absence on one side.

group of study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled.

You may qualify if:

• Patients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse.
• Informed consent freely granted and acquired before the start of the study.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

University of Milano Bicocca

Monza, MB, 20900, Italy

RECRUITING

Central Study Contacts

Matteo Frigerio, Dr

CONTACT

3406002013; frigerio86@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: July 28, 2022
• Study Start: April 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)