Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery
NCT ID: NCT01955798
Last Updated: 2020-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-01-31
2017-10-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trocar
Pyramidal tip reusable 11mm trocar
Laparoscopic direct entry Trocar
Laparoscopic direct entry with trocar
Trocar
Veress needle
Veress needle
Laparoscopic entry Veress needle
Laparoscopic entry with Veress needle
Veress needle
Interventions
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Laparoscopic direct entry Trocar
Laparoscopic direct entry with trocar
Laparoscopic entry Veress needle
Laparoscopic entry with Veress needle
Trocar
Veress needle
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* three or more previous abdominal surgeries
18 Years
80 Years
FEMALE
No
Sponsors
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Fundacion Dexeus
OTHER
Responsible Party
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Ignacio Rodriguez MSc
Epidemilolgy
Principal Investigators
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Alberto Vazquez, MD
Role: PRINCIPAL_INVESTIGATOR
Salut de la Mujer Dexeus
Locations
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Hospital Quiron Dexeus
Barcelona, , Spain
Countries
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References
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Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
Tinelli A, Malvasi A, Guido M, Tsin DA, Hudelist G, Stark M, Mettler L. Laparoscopy entry in patients with previous abdominal and pelvic surgery. Surg Innov. 2011 Sep;18(3):201-5. doi: 10.1177/1553350610393989. Epub 2011 Jan 18.
Related Links
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Related Info
Other Identifiers
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DEX2013001
Identifier Type: -
Identifier Source: org_study_id
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