NCT01955798

Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fundacion Dexeus · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Laparoscopic Gynecological Surgery

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic direct entry Trocar	Laparoscopic direct entry with trocar
PROCEDURE	Laparoscopic entry Veress needle	Laparoscopic entry with Veress needle
DEVICE	Trocar
DEVICE	Veress needle

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2013-10-08
• Last updated: 2020-02-12

Locations

1 site across 1 country: Spain