Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

Institut Universitari Dexeus

Status: Withdrawn

Conditions: Laparoscopic Gynecological Surgery

Treatments: Procedure: Laparoscopic direct entry Trocar; Procedure: Laparoscopic entry Veress needle; Device: Trocar; Device: Veress needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01955798

DEX2013001

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any woman suitable for laparoscopic gyneacological surgery

Exclusion criteria

• Previus supra-infra umbilical laparotomy
• three or more previous abdominal surgeries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Trocar

Experimental group

Description:

Pyramidal tip reusable 11mm trocar

Treatment:

Procedure: Laparoscopic direct entry Trocar

Device: Trocar

Veress needle

Active Comparator group

Description:

Veress needle

Treatment:

Procedure: Laparoscopic entry Veress needle

Device: Veress needle