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临床试验/NCT06792331
NCT06792331已完成不适用

Vaginal Natural Orifice Transluminal Surgery High Uterosacral Ligament Suspension Versus Laparoscopic Lateral Suspension in the Management of Vaginal Vault Prolapse: Initial Experience in a Single Center With a Median-term Follow-up

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Anatomical and functional outcomes

研究概览

简要总结

Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration.

详细描述

Hysterectomy is one of the common surgical procedures in current gynecology practice and is a risk factor for vault prolapse. Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration. Lack of incision pain, better cosmetic results, and direct visualization of important structures such as the rectum and ureter that cannot be obtained with the traditional transvaginal approach are important advantages of vNOTES approach.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with vaginal vault prolapse

排除标准

  • Women who have previously undergone surgical treatment for pelvic organ prolapse
  • Women who needed additional surgery due to anterior or posterior prolapse or stress incontinence
  • Pelvic inflammatory disease
  • Suspected gynecological malignancy
  • Rectovaginal endometriosis
  • obliterated rectovaginal space detected on pelvic examination.

结局指标

主要结局

Anatomical and functional outcomes

时间窗: 14-30 months

Evaluation of Pelvic organ prolapse quantification (POP-Q) scores before and after surgeries. Clinical assessment of the pelvic floor was performed by a gynecologist experienced in the evaluation of pelvic organ prolapse, while patients were in the supine lithotomy position. In the POP-Q, nine measurement points are assessed during the maximal Valsalva maneuver, except for the transvaginal length (TVL), measured at rest. Only the measurements of POP-Q points Ba, C, Bp were used to compare preoperative and postoperative evaluation. Ba is the most descended edge on the anterior vaginal wall, C represents either the most distal edge of the cervix or the leading edge of the vaginal vault, Bp is the most descended edge on the posterior vagina wall. Measurements in centimeters relative to the hymenal remnants were used in the analysis.

Requirement of reoperation

时间窗: 14-30 months

Number and rate of women requiring subsequent surgery for pelvic organ prolapse following the studied surgeries.

Subjective recurrence

时间窗: 14-30 months

The presence of bulging symptoms

次要结局

  • Transition of patient condition after surgery(6 months)
  • Sexual Function(6 months)
  • Change in quality of life(6 months)
  • Change of sexual function(6 months)
  • Parameters regarding surgery(14-30 months)

研究者

发起方
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arzu Bilge Tekin

Assoc. Prof. MD

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

研究点 (1)

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