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临床试验/NCT01976000
NCT01976000已完成不适用

The Impact of Preoperative Knowledge of the Colonic Vascular Anatomy on the Learning Curve for Laparoscopic Colorectal Resection

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
operating time

研究概览

简要总结

Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the well-known benefits and comparable oncological outcomes, it is still limited by a lack of tactile sensation and a reduced operative field view. In addition, the inconsistency in the number and course of the mesenteric vessels significantly influences the learning curve with 30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy can be mapped using CT-angiography, and the images can be processed with rendering software to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was to assess the influence of visualizing the three-dimensional vascular anatomy on the learning curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on the learning curve, we considered 2 groups of two surgeons with different levels of experience. In the first group (group A), the surgeons were able to view 3D reconstructions before and during the surgery, while the surgeons in Group B were only able to view the 3D reconstructions after surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in which standard laparoscopic right or left hemicolectomy was planned

排除标准

  • patients who underwent extended right hemicolectomy and segmental colectomy or sigmoidectomy and patients for whom the surgical technique was modified intraoperatively
  • patients who underwent anterior rectal resection and emergency procedures for complicated diverticulitis were excluded because these procedures require higher technical skills.
  • Patients who had an ASA score of IV, a BMI over 40 or contraindications for laparoscopy were also excluded.

结局指标

主要结局

operating time

时间窗: operating time

次要结局

  • intraoperative and postoperative complications(first 2 week after surgery)
  • oncological clearance(first 2 weeks after surgery)
  • hospital stay(first 2 weeks after surgery)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Saverio Mari

MD

University of Roma La Sapienza

研究点 (1)

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