Three Laparoscopic Access Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cafa Ester Valentina, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01597362
First received: May 9, 2012
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Benign Gynecological Pathology
Procedure: laparoscopy
Procedure: Laparoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • minor complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications


Enrollment: 608
Study Start Date: February 2006
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Veress needle technique Procedure: Laparoscopy

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.

Direct trocar technique Procedure: Laparoscopy

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.

Open technique Procedure: laparoscopy
Trocar access in laparoscopy
Procedure: Laparoscopy
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Campus Bio-Medico University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cafa Ester Valentina, Principal Investigator, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01597362     History of Changes
Other Study ID Numbers: TRC-01
Study First Received: May 9, 2012
Last Updated: May 11, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Campus Bio-Medico University:
laparoscopy
trocars
veress
open
direct

ClinicalTrials.gov processed this record on October 22, 2014