NCT05192954已完成不适用
Comparing Postoperative Pain After LigaSureTM Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Marlana McDowell2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年1月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Postoperative Pain
研究概览
简要总结
This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.
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)
盲法说明
Participant will be under anesthesia and will not know which surgical method is being utilized.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English speaking, able to understand informed consent
- •Vaginal hysterectomy with vaginal vault suspension
- •with or without anterior and posterior repairs
- •with or without removal of fallopian tubes or ovaries
- •with or without procedures for stress urinary incontinence
排除标准
- •Use of mesh for prolapse repair
- •Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
- •Concomitant procedure done by an additional surgeon
- •Concomitant anal sphincteroplasty or rectovaginal fistula repair
- •History of chronic pelvic pain receiving medical care
- •Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
- •Pregnancy
研究组 & 干预措施
Vessel sealing device
Experimental
Vessel sealing device to be utilized for vaginal hysterectomy
干预措施: LigaSureTM vessel sealing device (Device)
Conventional clamping and suturing method
No Intervention
Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material.
结局指标
主要结局
Postoperative Pain
时间窗: 3-6 hours postoperative
Visual Analog Scale, 0-10, with 10 being "most severe pain"
次要结局
- Abdominal Pain(3-6 hours postoperative)
- Vaginal Pain(3-6 hours postoperative)
研究者
Marlana McDowell
Female Pelvic Medicine and Reconstructive Surgery Fellow
TriHealth Inc.
研究点 (2)
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