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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 9, 2012
Last Updated Date	May 11, 2012
Start Date ^ICMJE	February 2006
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 11, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01597362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Three Laparoscopic Access Techniques
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Benign Gynecological Pathology
Intervention ^ICMJE	Procedure: laparoscopy Trocar access in laparoscopy 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. 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. 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.
Study Arm (s)	Veress needle technique Intervention: Procedure: Laparoscopy Direct trocar technique Intervention: Procedure: Laparoscopy Open technique Interventions: Procedure: laparoscopy Procedure: Laparoscopy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	608
Completion Date	September 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01597362
Other Study ID Numbers ^ICMJE	TRC-01
Has Data Monitoring Committee	No
Responsible Party	Cafa Ester Valentina, Campus Bio-Medico University
Study Sponsor ^ICMJE	Campus Bio-Medico University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Campus Bio-Medico University
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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