Three Laparoscopic Access Techniques

Not Applicable

Completed

• Conditions: Benign Gynecological Pathology
• Interventions: Procedure: Laparoscopy

• Registration Number: NCT01597362
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

The study compares the Veress needle technique, the Direct trocar insertion and the Open technique with each other, in terms of minor complications, in elective laparoscopic procedures for benign pathologies.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2010-05
• Study Completion: 2010-09
• Status Verified: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-11
• Last Update Submitted: 2012-05-11
• Study First Posted: 2012-05-14
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 608

Inclusion Criteria

• not-obese adult patients referred for scheduled laparoscopic and gynecologic procedures,
• benign pathology
• no previous abdominal surgery
• Age range was 18-70 years

Exclusion Criteria

• obesity, defined as a body mass index (BMI) > 30 kg/m2
• previous abdominal surgery by laparoscopy or laparotomy
• history of PID
• irritable Bowel Syndrome
• suspicion of malignancy or malignancy at the histological examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Veress needle technique	Laparoscopy	-
Direct trocar technique	Laparoscopy	-
Open technique	Laparoscopy	-

Primary Outcome Measures

Name	Time	Method
minor complications	1 year	feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications