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临床试验/NCT03306238
NCT03306238Unknown不适用

Laparoscopic Entry Technique in Renal Surgery: a Randomised Controlled Trial Comparing Open (Hasson) Versus Closed (Veress) Techniques.

The Adelaide and Meath Hospital, incorporating The National Children's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Complications

研究概览

简要总结

This is a randomised controlled trial to evaluate safety and efficacy of two different port site entry techniques in laparoscopic renal surgery: open method (Hasson) and closed method (Veress). It will involve 300 adult patients undergoing elective laparoscopic renal surgery in Tallaght hospital under two Consultant urologists.

详细描述

Surgical specialties commonly using laparoscopic techniques like gynecology and general surgery have extensively compared the various available techniques of port insertion (1). There is very little known regarding the safest entry technique for the initial port in laparoscopic renal surgery. Results from other surgical specialties cannot simply be extrapolated to this type of laparoscopic surgery due to difference in entry site and patient position with renal surgery. Hence, this randomised controlled trial will be performed in a urological unit with two laparoscopic renal surgeons to compare two commonly used techniques of initial trocar insertion: the closed method and the open method.

Background Since its introduction in 1991 by Clayman, laparoscopic renal surgery has become very popular and is widely used for both benign and malignant renal operations such as radical, simple and partial nephrectomies, pyeloplasties, nephro-ureterectomies (2). The overall reported major and minor complication rate of laparoscopic renal surgery is 9.5% and 1.9% respectively (2). Initial entry by trocar insertion is the most hazardous part of the laparoscopic procedure. Opinion regarding the safest entry technique is divided. The two most commonly used techniques of port entry include open and closed (3). An open technique, as first described by Hasson, involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope. One of the closed technique involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity). Finally the laparoscope is passed through the trocar once the obturator is removed. Previous meta-analyses in laparoscopic surgery from gynaecological and general surgical operations have not been able to support one technique over the other due to insufficient evidence.to our knowledge (3), there are no randomised controlled trials comparing these two techniques in laparoscopic renal surgery. During laparoscopic renal surgery, the patient is placed in a lateral flank position with the table flexed. The initial port of entry can be either at the umbilicus or lateral to it. This position is unique to urological surgery and hence can have different implications to the initial trocar insertion technique.

The objective is to compare the open method (Hasson) and closed method (Veress) of laparoscopic port site entry in renal surgery

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The patient and the investigator will not be informed of the type of approach they had. These will be marked as A and B with only the care povide/surgeon being aware of the actual approach. The investigator of complications and assessor of the case outcomes will collect data without the knowledge of the group the patient belongs to. The surgeon or car eprovider cannot be masked in this case due to technical limitations but they will not contribute towards analysing the results.

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

  • •• Able to undergo a general anaesthetic
  • •At least 18 years old
  • •Willing and able to give AN INFORMED CONSENT

排除标准

  • •patient refusal obese patients BMI >40mg/m2 previous laparotomy

研究组 & 干预措施

Open/Hasson

Active Comparator

This group will undergo initial laparoscopic port insertion by the open or Hasson approach and then undergo the remaining laparoscopic surgery as usual

干预措施: Open approach to port insertion (Procedure)

Closed/ Veress

Active Comparator

This group will undergo initial laparoscopic port insertion by the closed or Veress approach and then undergo the remaining laparoscopic surgery as usual

干预措施: Closed approach to port insertion (Procedure)

结局指标

主要结局

Complications

时间窗: 48 hours

Minor and major complications assessed

次要结局

  • Time to insertion(30 minutes)

研究者

发起方
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arun Thomas

Principal investigator

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

研究点 (1)

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