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临床试验/NCT03506555
NCT03506555已完成不适用

Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique: A Randomised Controlled Trial

Sefako Makgatho Health Sciences University0 个研究点目标入组 96 人开始时间: 2014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
状态
已完成
入组人数
96
主要终点
complications/adverse events related to the technique

研究概览

简要总结

A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either emergency or elective surgical procedures was conducted over a 13-month period. The success rate and complications related to the technique were recorded and analysed.

详细描述

A randomised controlled trial (RCT) was conducted at the single academic tertiary institution (Dr George Mukhari Academic Hospital (DGMAH), South Africa). Patients were recruited over a 13-month period (from 1st November 2014 to 30th November 2015). All haemodynamically stable patients undergoing either emergency or elective laparoscopic procedures were offered to participate in the study. General surgical patients 18 years or older who were eligible to provide an informed written consent were included in the study. Patients younger than 18 years old and haemodynamically unstable patients were excluded from the study. The success rate and complications related to the technique were recorded and analysed.

All included patients were randomised by computer program into one of two arms of the study: the arm A (Veress needle) or the arm B (Hasson). Participating surgeons were fully proficient with both techniques. The periumbilical area and the left hypochondrium (Palmer's point) were the recommended sites of entry, however, depending on clinical situation a surgeon could opt the other areas. In the A arm, a standard reusable Veress needle was used guided by tactile clicks feeling and water drop test. After pneumoperitoneum was established, the trocar was introduced in the same area. In the B arm, the standard open Hasson technique was used by dissecting tissues and dividing peritoneum between two forceps and introducing the port (a sleeve) without a trocar under direct visualization. Failed entry was defined as an inability to access the peritoneal cavity by a surgeon using the access technique initially selected.

An anonymized data collection form was completed by the general surgeon responsible for the procedure. Patients' age, gender, height, weight, diagnosis, type of surgery, previous abdominal surgery, previous abdominal tuberculosis (TB), primary port site placement, a surgeon, intraabdominal findings, complications and their type were recorded. Body Mass Index (BMI) was calculated and patients were categorised into weight groups: BMI above 30 and below 30.

All patients were followed up in 24 hours to detect the early entry-site complications. The complication after 24 hours, including surgical site infection and port-site hernia were not included in the design of this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

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

  • •haemodynamically stable patients, undergoing either emergency or elective laparoscopic general surgical procedures

排除标准

  • •haemodynamically unstable patients, invalid consent

研究组 & 干预措施

the arm A (Veress needle)

Active Comparator

a standard reusable Veress needle technique was performed for laparoscopic entry

干预措施: Laparoscopic peritoneal entry technique: Veress needle versus Hasson (Procedure)

the arm B (Hasson)

Active Comparator

the standard open Hasson technique was performed for laparoscopic entry

干预措施: Laparoscopic peritoneal entry technique: Veress needle versus Hasson (Procedure)

结局指标

主要结局

complications/adverse events related to the technique

时间窗: within 24 hours

Any complications related to the technique

the success rate

时间窗: during surgery

The technique resulted in establishment of pneumoperitoneum

次要结局

  • Conditions leading to complications/adverse events(within 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Oleh Matsevych

Dr OY Matsevych (Department of Surgery)

Sefako Makgatho Health Sciences University

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