跳至主要内容
临床试验/NCT00456170
NCT00456170Unknown1 期

Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy

Southern Health2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年4月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
60
试验地点
2
主要终点
Pain score

研究概览

简要总结

The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

详细描述

Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent.

After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data.

A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above.

The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Any patient already on waitlist requiring vaginal hysterectomy

排除标准

  • No patient consent

结局指标

主要结局

Pain score

Time to discharge

Blood loss

次要结局

  • Cost
  • Complications

研究者

发起方
Southern Health
申办方类型
Other

研究点 (2)

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