跳至主要内容
临床试验/NCT05895058
NCT05895058招募中不适用

Comparison of 2D 4K vs. 3D HD Laparoscopic Imaging Systems in Bariatric Surgery: a Randomized Controlled Prospective Trial

Marko Kraljevic1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Operation time

研究概览

简要总结

Laparoscopy has become an indispensable part of modern surgery. Vision is an important and defining element of laparoscopy and significantly affects the outcome of an operation in regard to time, mistakes and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD), and two-dimensional (2D) ultra-high-resolution (4K) monitors. In experimental and clinical settings, several studies have been published in recent years suggesting that 3D systems present a number of potential benefits for surgeons and patients compared to the conventional 2D systems. The 3D HD system significantly reduces operation time and blood loss, and additionally shortens hospital stay. However, the performance of 3D systems against the new, ultra-high-definition 4K systems is barely known and highly controversial. There is a paucity of studies comparing these two imaging systems in clinical settings. The goal of this clinical trial is to compare 2D 4K versus 3D HD imaging systems in a complex bariatric surgery, more precisely a gastric bypass operation. The investigators aim to investigate the hypothesis stating that the use of the 3D HD system yields a significant improvement in operating time compared to a 2D 4K system in bariatric laparoscopic surgery. Furthermore, in order to give a comprehensive overview of the comparison of 2D 4K and 3D HD laparoscopy in a clinical setting, the investigators will assess the workload of the surgeon as well as the intraoperative and postoperative complications including the hospitalization time.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with the indication for gastric bypass according to SMOB guidelines: BMI > 35, Age > 18 and Cumulative two years of controlled conservative dieting without weight loss
  • Informed Consent signed by the patient

排除标准

  • Patients who do not have an indication for gastric bypass due to one or more of the criteria listed here: BMI > 50, Lack of adequate weight loss therapy for two years, Malignant disease, Liver cirrhosis Child A, Morbus Crohn, Carcinoma patients, Serious mental illness requiring treatment (not attributable to obesity), Chronic abuse of drugs, Lack of compliance (missed appointments, inability to cooperate), Lack of understanding of the requirements and conditions of postoperative therapy and treatment (confirmed by the specialist)
  • Patient does not sign Informed Consent

结局指标

主要结局

Operation time

时间窗: intraoperative

Operation time (OT) is defined from the beginning of the operation by incision of the skin to the end of the operation by the end of the skin suture.

次要结局

  • Intraoperative Complications(Immediately after surgery up to one day postoperatively)
  • Postoperative Complications(Follow-up until the first postoperative Check-up after three months)
  • Workload of the operating surgeon(Immediately after surgery)

研究者

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

Marko Kraljevic

PD Dr. med.

Clarunis - Universitäres Bauchzentrum Basel

研究点 (1)

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