Clinical trial NCT05477043: Ureteral Patency After Uterosacral Ligaments Suspension
Official title: Ultrasound Evaluation of Ureteral Patency After Uterosacral Ligaments Suspension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterovaginal Prolapse
Ureteral Injury
Surgery--Complications
Keywords: Uterovaginal prolapse
uterosacral ligament suspension
ureteral patency
ultrasound
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled.

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.

Detailed description: It's a prospective observational monocentric study. 100 consecutive patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled. Considering the surgical activity of our department we plan to enroll this number of patients within 18 months. After the surgical procedure, while still in the operatory room, they will be subjected to ultrasound evaluation of ureteral patency before being subjected to diagnostic cystoscopy. Ultrasound will be performed before cystoscopy in order not to be influenced by the results of the gold standard procedure. Ultrasound and cystoscopy will be performed by different operators in order not to be influenced by the results.

Intravenous somministration of 300 ml of saline solution will be performed 10 to 15 minutes before the end of the surgical procedure. Bladder will be filled with 300 ml of mannitol solution. All ultrasounds will be obtained with a convex 3.5-MHz probe. Ultrasound examination of the bladder will be performed in transverse planes. Bilateral simultaneous ureteral jet evaluation with power Doppler will be performed at the level of the ureterovesical junctions with a pulse repetition frequency set to detect low flow for 3 minutes, as previously described. The power Doppler field size will include the entire posterior wall of the bladder. Ureteral patency test will be considered normal if jets will be present at least once on each side. It will be considered abnormal when either absent or comparatively diminished on the ipsilateral side and well visualized on the contralateral side. It will be considered nondiagnostic when neither side was visualized during the 3 minutes. Ultrasound test results will be noted and after that diagnostic cystoscopy will be performed.

Postoperative care will be usual.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

None

Primary outcomes:
measure: Detection of ureteral patency
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Duration
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Monza
country: Italy
facility: University of Milano Bicocca
state: MB
Study officials:
References: