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临床试验/NCT04209036
NCT04209036Unknown不适用

2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
试验地点
1
主要终点
Operative time

研究概览

简要总结

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

详细描述

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.

While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope (HD EndoEye 10 mm, Olympus Winter & IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter & IBE GMBH, Hamburg - Germany). The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique used by the recruiting center (development of the pararectal space and identification of uterine artery, coagulation of ovarian pedicles, development of the vesico-uterine septum, colpotomy).The vaginal vault is then closed with a 0 Vycril suture laparoscopically (continuous suture).

Detailed operative time, intra and post operative early complications will be recorded (Extended Clavien-Dindo classification of surgical complications will be used for post operative complications)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy
  • Uterine size </= than 15 cm
  • American Society of Anesthesiologists (ASA) class < 3
  • Patient's informed consent
  • No actual pregnancies or pelvic inflammatory disease
  • No previous major abdominal surgical procedures

排除标准

  • Suspected neoplastic pathology
  • Patients not eligible for surgery

结局指标

主要结局

Operative time

时间窗: intra-operative

To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

次要结局

  • Intra-operative complications(intra-operative)
  • Early post-operative complications(from surgery up to 30 days from surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Giovanni Scambia

Professor

Catholic University of the Sacred Heart

研究点 (1)

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