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

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Laparoscopic Entry Technique
• Intervention / Treatment: Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• haemodynamically unstable patients, invalid consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the arm A (Veress needle); a standard reusable Veress needle technique was performed for laparoscopic entry	Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson; According to randomization, the closed (Veress needle) or the open (Hasson) laparoscopic entry technique was utilized for general surgical operations
Active Comparator: the arm B (Hasson); the standard open Hasson technique was performed for laparoscopic entry	Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson; According to randomization, the closed (Veress needle) or the open (Hasson) laparoscopic entry technique was utilized for general surgical operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate	The technique resulted in establishment of pneumoperitoneum	during surgery
complications/adverse events related to the technique	Any complications related to the technique	within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditions leading to complications/adverse events	Any conditions leading to complications/adverse events were analyzed	within 24 hours

Collaborators and Investigators

• Sponsor: Sefako Makgatho Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 14, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: complications; Laparoscopy; Hasson technique; Veress needle technique
• Other Study ID Numbers: SefakoMSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No