跳至主要内容
临床试验/CTRI/2022/01/039299
CTRI/2022/01/039299尚未招募不适用

Effects of Horizontal vs Vertical Vaginal Cuff Closure Techniques on Vagina Length and Sexuality after Vaginal Hysterectomy: -a randomized controlled trial.

Department of obs gynae AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively

研究概览

简要总结

The American Association of Gynecologic Laparoscopists (AAGL) recommends that “most hysterectomies for benign disease should be performed either vaginally or laparoscopically.†PFDs (pelvic floor diseases) includes vaginal bulging, urinary or fecal incontinence, pelvic organ prolapse (POP), pelvic pain, pelvic pressure or a sense of heaviness, difficulties emptying the bladder, and other sensory and emptying abnormalities of the gastrointestinal tract. These complaints can cause sexual inactivity. Given the sensitive nature of prolapse with its effect on physical appearance of female genitals, particularly when the condition is advanced, it seems likely that such prolapse would render at least some women self-conscious. Major concern after POP surgery includes not only successful anatomical correction of any protrusion but also the impact of surgery on the quality of life including sexual life.

Only a few prospective comparative studies on sexual function before and after POP surgery have been conducted, and only a few studies have attempted to define the optimal method of vaginal cuff closure after vaginal hysterectomy (VH). Those that have, have done so only in terms of the effects of the closure type on vaginal length; they did not assess the effects of various techniques on sexual functioning. To address this area, we prospectively evaluated sexual function in women before and after VH with McCall Culdoplasty and compared the effects of horizontal and vertical vaginal cuff closure on sexuality.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • •All the cases of benign Pelvic organ prolapse with Stage 2 or higher (measured using pelvic organ prolapse quantification system) will be enrolled in the study.

排除标准

  • •Malignant pelvic organ prolapse suspicious to be malignant.

结局指标

主要结局

The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively

时间窗: Vaginal Length [ Time Frame: up to 4-6 weeks post-operative] | The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively

Vaginal Length [ Time Frame: up to 4-6 weeks post-operative]

时间窗: Vaginal Length [ Time Frame: up to 4-6 weeks post-operative] | The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively

次要结局

  • Intraoperative observation including:(1. Operative time)

研究者

发起方
Department of obs gynae AIIMS Rishikesh
申办方类型
Research institution and hospital

研究点 (1)

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