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临床试验/NCT03770897
NCT03770897已完成不适用

Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
1
主要终点
Operative time.

研究概览

简要总结

Laparoscopy has revolutionized the approach to a number of surgical problems causing a re-evaluation of several clinical strategies. Now it has become the standard treatment for majority of ailments including symptomatic gall stone disease, appendicitis, GERD (gastroesophageal reflux disease), morbid obesity and colorectal disease. All these developments aim at minimizing perioperative morbidities, providing rapid postoperative recovery and enhancing patient's safety profile. One of the major limitations of conventional laparoscopy is lack of depth perception. Introduction of 3D imaging, has removed many of these technical obstacles. In 1993, Becker et al., reported that a 3D display might improve laparoscopic skills. Since then, many researchers have demonstrated benefit of 3D imaging . Starting from this, we can theorize an impact of 3D technologies on surgeon's learning curves. This concern is recently being demonstrated in experimental and clinical setting with improvement of hand-eye coordination, better laparoscopic skills and less time to learn surgical procedure. Usually junior surgeons (JS) start their activities with cholecystectomy and appendectomy but, despite an amount of literature regarding the first procedure, there is a 'black hole' regarding the use of 3D imaging in laparoscopic appendectomy (LA).

The investigators decided to investigate the impact of 3D visualization on surgeons' and surgical outcome during laparoscopic appendectomy (LA) performed by junior surgeons (JS). Operative details and clinical aspect are both take in account in order to looking for any advantages or concerns conferred on JS in performing LA.

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, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All adult patients scheduled to undergo laparoscopic appendectomy. Ages eligible for study: >18 Sexes eligible for study: All

排除标准

  • •Patients who decline to join the study
  • •Patients under 18 years old
  • •Patients with contraindication to undergo laparoscopic surgery.
  • •Patients without appendicular disease found at laparoscopy (such as complicated inflammatory bowel disease, tumor, complicated diverticula, gynecological disorder)
  • •Patients undergoing open appendectomy

研究组 & 干预措施

3D laparoscopic appendectomy.

Experimental

Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.

干预措施: 3D Laparoscopic Appendectomy (Procedure)

2D laparoscopic appendectomy.

Active Comparator

Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.

干预措施: 2D Laparoscopic Appendectomy (Procedure)

结局指标

主要结局

Operative time.

时间窗: 1 minute after surgery

Time taken for the completion of the procedure

次要结局

  • Conversion to open appendectomy.(1 minute after surgery)
  • Intraoperative complication(1 minute after surgery)
  • Surgeon's comfort(1 hour after surgery)
  • Post-operative complication. morbidity, readmission at 30th days, mortality(30 days)

研究者

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

Nereo Vettoretto

Head of Surgery, Principal Investigator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

研究点 (1)

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