Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Institut Universitari Dexeus
Sponsor:
Information provided by (Responsible Party):
Ignacio Rodriguez, Institut Universitari Dexeus
ClinicalTrials.gov Identifier:
NCT01955798
First received: September 20, 2013
Last updated: October 7, 2013
Last verified: September 2013
  Purpose

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

Condition Intervention
Laparoscopic Gynecological Surgery
Procedure: Laparoscopic direct entry Trocar
Procedure: Laparoscopic entry Veress needle
Device: Trocar
Device: Veress needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study

Further study details as provided by Institut Universitari Dexeus:

Primary Outcome Measures:
  • Complications during entry in laparoscopy [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
    Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc


Secondary Outcome Measures:
  • Time to enter in the abdominal cavity [ Time Frame: During surgery ] [ Designated as safety issue: No ]
    Time in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trocar
Pyramidal tip reusable 11mm trocar
Procedure: Laparoscopic direct entry Trocar
Laparoscopic direct entry with trocar
Device: Trocar
Active Comparator: Veress needle
Veress needle
Procedure: Laparoscopic entry Veress needle
Laparoscopic entry with Veress needle
Device: Veress needle

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any woman suitable for laparoscopic gyneacological surgery

Exclusion Criteria:

  • Previus supra-infra umbilical laparotomy
  • three or more previous abdominal surgeries
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955798

Contacts
Contact: Alberto Vazquez, MD 0034616673050 albvaz@dexeus.com

Locations
Spain
Hospital Quiron Dexeus Not yet recruiting
Barcelona, Spain, 08028
Contact: Ignacio Rodriguez, BsC         
Sponsors and Collaborators
Institut Universitari Dexeus
Investigators
Principal Investigator: Alberto Vazquez, MD Salut de la Mujer Dexeus
  More Information

Additional Information:
Publications:
Responsible Party: Ignacio Rodriguez, Epidemilolgy, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT01955798     History of Changes
Other Study ID Numbers: DEX2013001
Study First Received: September 20, 2013
Last Updated: October 7, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Institut Universitari Dexeus:
Laparoscopy
Gyneacological
Entry techniques

ClinicalTrials.gov processed this record on September 18, 2014