Skip to content

Three Laparoscopic Access Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01597362
Enrollment
608
Registered
2012-05-14
Start date
2006-02-28
Completion date
2010-09-30
Last updated
2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Gynecological Pathology

Keywords

laparoscopy, trocars, veress, open, direct

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.

Interventions

PROCEDURElaparoscopy

Trocar access in laparoscopy

PROCEDURELaparoscopy

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.

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
minor complications1 yearfeasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026