Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

February 10, 2020 updated by: Ignacio Rodriguez MSc, Institut Universitari Dexeus

Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study

The Veress needle is the laparoscopic entry technique most commonly used among gynecologists. Direct trocar entry is another method to gain entry to the abdomen that is uncommon to gynecologists.

This prospective and randomized study will compare the two entry techniques with regard to:

  • Complications related to the entry technique and previous surgeries
  • Time taken to enter the abdomen
  • The number of attempts taken to enter the abdomen

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for gynecological purposes will participate in the study. Patients with previous middle laparotomies or 3 or more abdominal suregeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the two arms of the trial. All patient information will be confidential and only be available to researches involved in the study.

Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.

300 women will be recruited over a two year period and the data will be analysed by a statistician.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Hospital Quiron Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any woman suitable for laparoscopic gyneacological surgery

Exclusion Criteria:

  • Previus supra-infra umbilical laparotomy
  • three or more previous abdominal surgeries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trocar
Pyramidal tip reusable 11mm trocar
Procedure: Laparoscopic direct entry Trocar
Laparoscopic direct entry with trocar
Device: Trocar
ACTIVE_COMPARATOR: Veress needle
Device: Veress needle
Procedure: Laparoscopic entry Veress needle
Laparoscopic entry with Veress needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications during entry in laparoscopy
Time Frame: During surgery
Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to enter in the abdominal cavity
Time Frame: During surgery
Time in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Investigators

  • Principal Investigator: Alberto Vazquez, MD, Salut de la Mujer Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DEX2013001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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