NCT03506555

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

April 14, 2018

Last Update Submit

April 29, 2018

Conditions

Laparoscopic SurgeryLaparoscopic Entry Technique

Keywords

LaparoscopyHasson techniqueVeress needle techniquecomplications

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Conditions leading to complications/adverse events

    within 24 hours

Study Arms (2)

the arm A (Veress needle)

ACTIVE COMPARATOR

a standard reusable Veress needle technique was performed for laparoscopic entry

Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson

the arm B (Hasson)

ACTIVE COMPARATOR

the standard open Hasson technique was performed for laparoscopic entry

Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson

Interventions

Laparoscopic peritoneal entry technique: Veress needle versus HassonPROCEDURE

According to randomization, the closed (Veress needle) or the open (Hasson) laparoscopic entry technique was utilized for general surgical operations

the arm A (Veress needle)the arm B (Hasson)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • haemodynamically unstable patients, invalid consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr OY Matsevych (Department of Surgery)

Study Record Dates

First Submitted

April 14, 2018

First Posted

April 24, 2018

Study Start

November 1, 2014

Primary Completion

November 30, 2015

Study Completion

February 1, 2016

Last Updated

May 1, 2018

Record last verified: 2018-04