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临床试验/NCT05960292
NCT05960292Unknown不适用

Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
56
试验地点
1
主要终点
Post operative bleeding (defined as blood loss ≥500 cc)

研究概览

简要总结

Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

详细描述

Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.

Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.

The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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
否

入选标准

  • •Patients who undergo laparoscopic hysterectomy
  • •Age ranged from 40 to 80 years.
  • •Patients suffering from chronic pelvic inflammatory disease (PID)
  • •Dysfunctional uterine bleeding
  • •Adenomyosis
  • •Endometriosis
  • •Endometrial hyperplasia
  • •Benign ovarian cyst

排除标准

  • •Patients with known malignancy

研究组 & 干预措施

Vaginal Hysterectomy (Group)

Active Comparator

About 28 female patients will have vaginal vault closure by vaginal approach

干预措施: Laparoscopic and Vaginal Hysterectomy (Procedure)

Abdominal Laparoscopic Hysterectomy (Group)

Active Comparator

About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach

干预措施: Laparoscopic and Vaginal Hysterectomy (Procedure)

结局指标

主要结局

Post operative bleeding (defined as blood loss ≥500 cc)

时间窗: First 24 hours after The Operations

Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.

Postoperative pain

时间窗: First 24 hours after The Operations

Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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