Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Transumbilical Single Incision Laparoscopic Appendicectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- wound infection rate
研究概览
简要总结
Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital stay and less wound complications. Most of the time, three small wounds of less than 10mm will be adequate enough for the completion of the surgery with minimal pain.
Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to the attention of single incision laparoscopic surgery (SILS) again in the surgical community. SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et al. However, the close proximity of the instruments, limitation in triangulation during dissection and suboptimal exposure of the surgical field has made this approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has recently release their preliminary results on the use of SILS on appendicectomy with satisfactory results in terms of less post-operative pain and less prominent scar. However, it was a case series with limited number of patients. In order to test the advantages of SILS on the management of patients with acute appendicitis, a double blinded randomized clinical trial is conducted.
详细描述
Double Blinded Randomized controlled study of Conventional Laparoscopic Appendectomy Vs Transumbilical Single Incision Laparoscopic Appendicectomy
Introduction:
Laparoscopic appendicectomy is widely practiced in HA hospital nowadays with shorter hospital stay and less wound complications. Most of the time, three small wounds of less than 10mm will be adequate enough for the completion of the surgery with minimal pain.
Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to the attention of single incision laparoscopic surgery (SILS) again in the surgical community[1,2,3] is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et al. However, the close proximity of the instruments, limitation in triangulation during dissection and suboptimal exposure of the surgical field has made this approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has recently release their preliminary results on the use of SILS on appendicectomy with satisfactory results in terms of lesser post-operative pain and less prominent scar. However, it was a cases series with limited number of patients. In order to test the advantages of SILS on the management of patients with acute appendicitis, a double blinded randomized clinical trial is conducted.
Statistical 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be at least 18 years of age.
- •Male or female (excluding pregnant females).
- •Patients with ASA ≦
- •Patients informed about the study, and will have read; understood and signed the patient informed consent. Patients will be willing and able to submit to postoperative follow-up evaluations.
排除标准
- •Patients have previous history of abdominal surgery.
- •Patients with ASA >
- •Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
- •Patients who are incompetent in giving consent.
研究组 & 干预措施
single port
Patients will undergo transumbilical single incision laparoscopic appendicectomy.
干预措施: transumbilical single incision laparoscopic appendicectomy (Procedure)
conventional Lap
Patients will undergo conventional laparoscopic appendicectomy.
干预措施: conventional laparoscopic appendicectomy (Procedure)
结局指标
主要结局
wound infection rate
时间窗: 2 weeks after surgery
次要结局
- cosmetic satisfaction(2 weeks after surgery)
研究者
Kwok-Kay Yau
Specialist in general surgery
Pamela Youde Nethersole Eastern Hospital