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临床试验/NCT03436147
NCT03436147已完成不适用

Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse: a Prospective Randomized Study

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Number of Participants With Recurrence of Pelvic Organ Prolapse

研究概览

简要总结

Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on patient-centered medicine and patient-generated definitions of surgical success has resulted in reassessment of uterine preservation versus hysterectomy at the time of apical POP repair. Various techniques have been described for uterine preserving prolapse surgery, which may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was introduced and a series of 70 women was reported. To date, there have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension (hysteropexy) with conventional vaginal hysterectomy. Women attending the gynecology clinic at a tertiary referral urogynecology unit in tertiary referral training and research hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized trial, over a 2-year period. Subjects participating in the study were randomly assigned to either of two groups: Group A, Vaginally Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Mc Call Culdoplasty (VH + Mc Call).1 year following surgery, vaginal prolapse will be assessed again using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS) questionnaire and the Pelvic Organ Prolapse -Quantification (POP-Q) examination by another researcher then the operator.

详细描述

Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on patient-centered medicine and patient-generated definitions of surgical success has resulted in reassessment of uterine preservation versus hysterectomy at the time of apical pelvic organ prolapse (POP) repair. Comparison of study outcomes between hysteropexy and hysterectomy are confounded by anatomic variables (isolated apical prolapse or multiple compartment prolapse), hormonal status (premenopausal, postmenopausal on hormone therapy, and postmenopausal without hormone therapy), and surgical approach (vaginal, open abdominal, laparoscopic, and robotic). In addition, the number of women who subsequently undergo hysterectomy after a uterus-sparing prolapse surgery is not known. With the caveat of these limitations, new short-term data are available to inform consideration of uterine-sparing POP repair. Various techniques have been described for uterine preserving prolapse surgery, which may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was introduced and a series of 70 women was reported.To date, there have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension (hysteropexy) with conventional vaginal hysterectomy.

This is a single-center, randomized controlled study of two parallel groups. Women attending the gynecology clinic at a tertiary referral urogynecology unit requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized trial, over a 2-year period between February 2018 and February 2020.

Requirements for women recruited are that

  • patients who are over 35 years of age with no desire to preserve fertility. (Subjects had completed childbearing or were practicing reliable contraception)
  • have a normal size uterus (<10 cm) on examination or ultrasound
  • who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.

Investigators will exclude women with

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • patients who are over 35 years of age with no desire to preserve fertility. (Subjects had completed childbearing or were practicing reliable contraception)
  • have a normal size uterus (<10 cm) on examination or ultrasound
  • who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.

排除标准

  • cervical elongation (surgeon discretion),
  • prior mesh prolapse repair,
  • current foreign-body complications,
  • increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant uterine abnormalities, and abnormal menstruation.
  • postmenopausal bleeding in the past 12 months
  • women with a significantly enlarged fibroid uterus
  • concomitant medical problems precluding general anesthesia or the use of a steep trendelenberg position

结局指标

主要结局

Number of Participants With Recurrence of Pelvic Organ Prolapse

时间窗: Postoperative first year

Number of Participants with Recurrence of Pelvic Organ Prolapse

次要结局

  • POP-Q SYSTEM Point C MEASUREMENT(change from preoperative measurement of pop-q point c at postoperative first year)
  • ICIQ-VS Vaginal Symptom Subscale(change from preoperative ICIQ-VS vaginal symptom subscale score at postoperative first year)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ismail Alay

principal investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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