Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery
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
|Laparoscopic Gynecological Surgery||Procedure: Laparoscopic direct entry Trocar Procedure: Laparoscopic entry Veress needle Device: Trocar Device: Veress needle|
|Study Design:||Allocation: Randomized
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|
- 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
- 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
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Pyramidal tip reusable 11mm trocar
Procedure: Laparoscopic direct entry Trocar
Laparoscopic direct entry with trocarDevice: Trocar
Active Comparator: Veress needle
Procedure: Laparoscopic entry Veress needle
Laparoscopic entry with Veress needleDevice: Veress needle
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01955798
|Hospital Quiron Dexeus|
|Barcelona, Spain, 08028|
|Principal Investigator:||Alberto Vazquez, MD||Salut de la Mujer Dexeus|