Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

Not Applicable

Withdrawn

• Conditions: Laparoscopic Gynecological Surgery
• Interventions: Procedure: Laparoscopic entry Veress needle; Procedure: Laparoscopic direct entry Trocar; Device: Trocar; Device: Veress needle

• Registration Number: NCT01955798
• Lead Sponsor: Institut Universitari Dexeus

Brief 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.

Study Timeline

• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Start: 2015-01
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Any woman suitable for laparoscopic gyneacological surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trocar	Trocar	Pyramidal tip reusable 11mm trocar
Veress needle	Veress needle	Veress needle
Veress needle	Laparoscopic entry Veress needle	Veress needle
Trocar	Laparoscopic direct entry Trocar	Pyramidal tip reusable 11mm trocar

Primary Outcome Measures

Name	Time	Method
Complications during entry in laparoscopy	During surgery	Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc

Secondary Outcome Measures

Name	Time	Method
Time to enter in the abdominal cavity	During surgery	Time in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity

Trial Locations

Locations (1)

Hospital Quiron Dexeus; 🇪🇸 Barcelona, Spain