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Three Laparoscopic Access Techniques

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ClinicalTrials.gov Identifier: NCT01597362
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Cafa Ester Valentina, 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.

Condition or disease Intervention/treatment
Benign Gynecological Pathology Procedure: laparoscopy Procedure: Laparoscopy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : February 2006
Primary Completion Date : May 2010
Study Completion Date : September 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. minor complications [ Time Frame: 1 year ]
    feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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

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
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Cafa Ester Valentina, Campus Bio-Medico University: