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临床试验/NCT04410393
NCT04410393进行中(未招募)不适用

Comparison of the Sacrocolpopexy Operation and Lateral Suspension Operations Performed in the Treatment of Vaginal Cuff Prolapse in Patients With Hysterectomized Patients

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
complications

研究概览

简要总结

Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

详细描述

Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

研究设计

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

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who had previously undergone hysterectomy for benign causes
  • Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
  • And for this, patients scheduled for operation

排除标准

  • Patients with chronic diseases or medications that interfere with the operation
  • Patients with oncology operated for malignant cause
  • Non-localized patients with vaginal cuff prolapse

结局指标

主要结局

complications

时间窗: 1 years

Patients will be followed up for 1 year after the operation and will be evaluated for complications at 1, 6 and 12 months. bleeding ( bleeding rate will be specified in milliliters ) the risk of infection (According to the findings, there is an infection with / without infection.)

recurrence

时间窗: 1 years

Patients will be followed up for 1 year after surgery and will be evaluated for recurrence at 1, 6 and 12 months. degree of uterine desensus cystocele and rectocele degree to be examined Recurrence rate will be defined by pelvic examination according to POP-Q scoring.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Kadirogulları

Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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