Three Laparoscopic Access Techniques

Study Overview
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Brief Summary
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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.

Conditions
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Benign Gynecological Pathology

Intervention / Treatment
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* Procedure: laparoscopy
* Procedure: Laparoscopy
* Procedure: Laparoscopy
* Procedure: Laparoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Veress needle technique<br> | Procedure: Laparoscopy<br>* The angle of the Veress needle insertion is 45 for non-obese women. After insertion of the needle, tests to determinate its correct positioning are: the double click test, the aspiration test, the handing drop test, serial intrabdominal gas pressure measurements. The volume of CO2 inserted with the Veress needle depends on the intra-abdominal pressure. Adequate pneumoperitoneum should is determined by a pressure of 20 to 30 mm Hg and not by predetermined CO2 volume.<br>|
| Other: Direct trocar technique<br> | Procedure: Laparoscopy<br>* Direct insertion of the trocar is performed without prior pneumoperitoneum. Infra-umbilical skin incision is wide enough to accomodate the diameter of a sharp trocar/cannual system. The abdominal wall is elevated by pulling on, by hands, two towel clips placed 3 cm on either side of the umbilicus, and the trocar is inserted at a 90°angle. On removal of the sharp trocar, the laparoscope is inserted to confirm the presence of omentum or bowel in the visual field.<br>|
| Other: Open technique<br> | Procedure: laparoscopy<br>* Trocar access in laparoscopy<br>Procedure: Laparoscopy<br>* A small incision, 1 cm long, is made through the skin of the lower edge of the umbilical fossa. The skin and the subcutaneous adipose tissues are retracted with the Zimmerman dissectors. The anterior rectus fascia is incised with the scalpel. The dissection with the Zimmerman valves allows the exposure of the peritoneum. After the peritoneum is incised, the trocar is inserted under direct vision. The laparoscope is introduced and insufflation is started. At the end of the procedure the fascial defect is closed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minor complications | feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, trocars, veress, open, direct