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临床试验/NCT00484835
NCT00484835Unknown1 期

Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy

Southern Health3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年9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
3
主要终点
Operating time, Blood loss, Post-operative pain

研究概览

简要总结

The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp & suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.

详细描述

Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps & the other group with the traditional clamp & suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.

The researcher will collect relevant data including age of patient, medical & surgical history and data relating to both the primary & secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay & cost.

A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.

Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal & cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.

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 in Southern Health for abdominal hysterectomy with suspected benign pathology

排除标准

  • Patients without consent and/or with suspected malignant pathology

结局指标

主要结局

Operating time, Blood loss, Post-operative pain

时间窗: 1 year

次要结局

  • Length of hospital stay, Cost of the procedure(1 year)

研究者

发起方
Southern Health
申办方类型
Other

研究点 (3)

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