Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Laparoscopic Gynecological Surgery

Intervention / Treatment
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* Procedure: Laparoscopic direct entry Trocar
* Procedure: Laparoscopic entry Veress needle
* Device: Trocar
* Device: Veress needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any woman suitable for laparoscopic gyneacological surgery Exclusion Criteria: Previus supra-infra umbilical laparotomy three or more previous abdominal surgeries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trocar<br>Pyramidal tip reusable 11mm trocar | Procedure: Laparoscopic direct entry Trocar<br>* Laparoscopic direct entry with trocar<br>Device: Trocar<br> <br> |
| Active Comparator: Veress needle<br>Veress needle | Procedure: Laparoscopic entry Veress needle<br>* Laparoscopic entry with Veress needle<br>Device: Veress needle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications during entry in laparoscopy | 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 in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Gyneacological, Entry techniques