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临床试验/NCT02700997
NCT02700997已完成不适用

Uterosacral Ligament Suspension: A Radiographic Study of Anatomy and Suture Location

TriHealth Inc.2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Suture Location in Relation to the Surrounding Anatomy

研究概览

简要总结

This study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension. Characterization of the surrounding anatomy in a living model will enhance surgical technique by delineating safer suture locations and decrease the incidence of morbid complications for patients.

详细描述

Uterosacral ligament suspension Is a commonly performed procedure to support the vaginal apex at the time of pelvic reconstructive surgery for pelvic organ prolapse (POP). Despite being a well established durable option for patients, there is little research detailing ligament suspension suture location in the living model. The available literature is limited to cadaveric studies, which suggest suture placement is in close proximity to vital structures such as the ureter, blood vessels, rectum and nerves.

This study seeks to describe suture location in relation to the surrounding anatomy in postoperative patients following high uterosacral ligament suspension. The secondary aim is to determine safe zones for suture placement.

Seventeen women (aged 18-85) under the care of Cincinnati Urogynecology Associates, a physician group of TriHealth, who have chosen vaginal hysterectomy with uterosacral ligament suspension (USLS) as the treatment choice for pelvic organ prolapse (POP) will be enrolled.

At the time of surgery, a titanium vascular clip (size small) will be applied to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging.

On postoperative day (POD) 1, patients will undergo CT pelvis scans. The CT scan will involve administration of IV contrast for imaging of the ureters and vascular structures. The clip will fall off when the sutures dissolve at 12 weeks postoperatively. All patients will be asked to complete a lower extremity neurological questionnaire preoperatively and postoperatively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 18-85 with pelvic organ prolapse (POP) who have elected uterosacral ligament suspension (USLS) for treatment

排除标准

  • contraindication to computed tomography (CT), or intravenous (IV) contrast
  • those with claustrophobia
  • previous POP surgery
  • previous pelvic surgery to the fallopian tubes, ovaries, or rectum
  • previous pelvic radiation
  • known pelvic inflammatory disease or endometriosis
  • those with preexisting ureteral or vascular pathology or sacral anatomic abnormality
  • those with connective tissue disorders
  • those with preexisting neuropathy, chronic lower extremity pain disorders, or neurological disorders
  • those with renal anomalies such as pelvic kidney, duplication of the collecting system, prior nephrectomy
  • those with allergy to titanium
  • removal of the uterosacral sutures due to ureteral obstruction intraoperatively

结局指标

主要结局

Suture Location in Relation to the Surrounding Anatomy

时间窗: 1 day after surgery

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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