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临床试验/NCT01217866
NCT01217866已完成不适用

A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy

Womens Care0 个研究点目标入组 79 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
主要终点
Surgical time

研究概览

简要总结

Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.

详细描述

79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever >100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • none, observational study

排除标准

  • none, observational study

结局指标

主要结局

Surgical time

时间窗: Operating room time in minutes

The total time the subject spent in surgery was compared between the two groups

Estimated blood loss

时间窗: Blood loss during surgery in cc per minute

The total blood loss in cc per minutes operating was compared between the two groups

次要结局

未报告次要终点

研究者

发起方
Womens Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn OKeeffe MD

MD

Womens Care

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