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临床试验/NCT06776718
NCT06776718尚未招募不适用

Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications

Dr. Lutfi Kirdar Kartal Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
2
主要终点
the duration of surgery

研究概览

简要总结

This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.

A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • aged between 40 and 80 years
  • undergo hysterectomy for benign gynecological conditions

排除标准

  • history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
  • suspected gynecologic malignancies,
  • endometriosis,
  • tubal-ovarian abscesses,
  • pelvic organ prolapse exceeding grade 2,
  • individuals who refused to participate in the study

结局指标

主要结局

the duration of surgery

时间窗: The time from the beginning to the end of the operation

İnterval from initial incision to the completion of vaginal cuff closure (minute)

次要结局

  • Hospitalization time(through study completion, an average of 1 month)
  • VAS score(postoperative 6th and 24 th hour)
  • Uterin volume(through study completion, an average of 1 month)
  • Re-admission(within 1 month after discharge)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mehmet Mete Kırlangıç

Assoc Prof

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (2)

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