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临床试验/NCT05804617
NCT05804617已完成不适用

Dome-type (Modified C-incision) Extracorporeal Manual Morcellation During Laparoscopic Uterine Surgery: A Retrospective Analysis

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Morcellation speed

研究概览

简要总结

In-bag manual morcellation is a safe alternative procedure after FDA's discouragement of electronic power morcellator. The traditional wedging (V-type incision) or semicircular coring (C-type incision or ExCITE) method are the most common morcellation techniques. For beginners, it is somehow not that easy to get familiar with these methods. No teaching or learning experiences were reported. Therefore, we developed a dome-type (modified C-incision) technique to manually morcellate uteri leiomyoma or uterus at the time of laparoscopic surgery and report perioperative outcomes and the learning experiences of our residents for this technique from our two years of experience.

详细描述

Background: In-bag manual morcellation is a safe alternative procedure after FDA's discouragement of electronic power morcellator. The traditional wedging (V-type incision) or semicircular coring (C-type incision or ExCITE) method are the most common morcellation techniques. For beginners, it is somehow not that easy to get familiar with these methods. No teaching or learning experiences were reported.

Objective

To describe using a dome-type (modified C-incision) technique to manually morcellate uteri leiomyoma or uterus at the time of laparoscopic surgery and report perioperative outcomes and the learning experiences of our residents for this technique from our two years of experience.

Study Design: Retrospective review of consecutive laparoscopic myomectomies or hysterectomies performed between May 2020 and September 2022 in which the specimen was manually morcellated using the dome-type technique by surgeon or trainees.

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
Double (Participant, Care Provider)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women at any age undergoing laparoscopic surgeries with dome-type morcellation

排除标准

  • Women with extremely huge specimen (>2000 gm)

结局指标

主要结局

Morcellation speed

时间窗: During procedure

Weight of specimen (gram) divided by morcellation time (minute)

次要结局

  • Age(Before procedure)
  • Abdominal surgical history(Before procedure)
  • BMI (kg/m2)(Before procedure)
  • Stiffness(During procedure)
  • Pathology(1 week (after the pathologic report being released))
  • Umbilical wound size (cm)(During procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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