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临床试验/NCT02975401
NCT02975401已完成不适用

Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9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
50
试验地点
1
主要终点
duration of the operation

研究概览

简要总结

The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.

详细描述

Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects.

Robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the applicability of this technology within the field of general surgery.

For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the US have experiences in structured treatment programs.

From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery, including the laparoscopic TAPP inguinal hernia repair.

Main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. However, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 50 patients selected and operated by the PI.

排除标准

  • patients under the age of 18
  • pregnancy
  • BMI > 35
  • recurrent groin hernia
  • no Informed Consent

结局指标

主要结局

duration of the operation

时间窗: from the start of the operation until the end of the operation, approximately 3 hours

Recording of the operation time needed for robot-assisted TAPP groin hernia repair

次要结局

  • intra-operative complications(until 4 weeks post-operative)
  • post-operative complications(until 4 weeks post-operative)
  • Quality of Life(until 4 weeks post-operative)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Muysoms

surgeon

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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