跳至主要内容
临床试验/NCT04637022
NCT04637022Unknown不适用

4K Versus 3D Laparoscopic Colporraphy 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 50 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
operative time

研究概览

简要总结

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

详细描述

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

  • I TIME/OUT OF PROTOCOL TIME (performed by expert surgeons) 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° 4K high-definition telescope (VISERA UHD 4K 10 mm, Olympus Winter & IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter & IBE GMBH, Hamburg - Germany).

Two additional 5 mm ports are placed under direct visualization, in the right lower abdomen medial to the right obliterated umbilical artery and in the left lower abdomen lateral to the inferior epigastric vessels. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. 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.

  • II TIME/PROTOCOL TIME (performed by surgeon in training) The vaginal vault is closed with a 0 Vycril suture laparoscopically (continuous suture). In order to avoid excess operating time, 15 min was allocated for completion of cuff closure by surgeons-in-training, after which time the attending surgeon took over this task.

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 gynecological pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy and consequently need for laparoscopic suture of the vaginal cuff
  • American Society of Anesthesiologists (ASA) class < 3
  • Patient's informed consent

排除标准

  • Suspected neoplastic pathology
  • Patients not eligible for surgery
  • Actual pregnancies or pelvic inflammatory disease

结局指标

主要结局

operative time

时间窗: intra-operative

To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K laparoscopy

次要结局

  • Intra-operative complications(intra-operative)

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)

Loading locations...

相似试验

4K Versus 3D Laparoscopic Colporraphy by Surgeons in... | 临床试验