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临床试验/NCT03198065
NCT03198065Unknown不适用

The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
wound cosmesis

研究概览

简要总结

Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast, thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and effective, and further it achieves compatible results and outcomes in oncology and functional diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy, and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel disease). Under a superior heritage of surgical skills from Taiwan university hospital, we introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years, single-incisional laparoscopic surgery has emerged to become one of the focused topic in the world and seemly in our department. Through single-incision surgery, we attempted to minimize the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate two-step plans: first, by retrospective data collection, we can explain the clinical problems based on current statistical results. Second, based on prior (step 1) retrospective findings, a prospective study could be conducted for more evident results.

详细描述

The aim of this study is to compare two kinds of single-incision laparoscopic surgery setting including hand-made glove setting and commercialized single-incision multiport setting. The preoperative, intraoperative and postoperative data will be collected for analysis.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis
  • The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded

排除标准

  • Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery
  • Decide to receive non-surgical treatment of the acute appendicitis
  • Age<20, or could not exercise the right of autonomy or unwilling to participate the study

结局指标

主要结局

wound cosmesis

时间窗: around 2 years

The cosmesis is measure by the length of the incision

Postoperative pain

时间窗: around 2 years

Postoperative pain is measured by visual pain scale

次要结局

  • Operative time(around 2 years)
  • Visceral/vascular injuries(around 2 years)
  • Conversion(around 2 years)
  • Wound infection/surgical site infection(around 2 years)
  • Postoperative ileus(around 2 years)
  • Time to return work(around 2 years)
  • Intra-abdominal collection(around 2 years)
  • Length of hospitalization(around 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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