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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trocar | Experimental | Pyramidal tip reusable 11mm trocar |
|
| Veress needle | Active Comparator | Veress needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic direct entry Trocar | Procedure | Laparoscopic direct entry with trocar |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Vazquez, MD | Salut de la Mujer Dexeus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Quiron Dexeus | Barcelona | 08028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22336819 | Background | 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. | |
| 21245070 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Laparoscopic entry Veress needle |
| Procedure |
Laparoscopic entry with Veress needle |
|
| Trocar | Device |
|
| Veress needle | Device |
|