Three Laparoscopic Access Techniques

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Completed

CT.gov ID

NCT01597362

Collaborator

(none)

608

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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	Phase
Benign Gynecological Pathology	Procedure: laparoscopy Procedure: Laparoscopy Procedure: Laparoscopy Procedure: Laparoscopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

608 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

minor complications [1 year]
feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Campus Bio-Medico University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cafa Ester Valentina, Principal Investigator, Campus Bio-Medico University

ClinicalTrials.gov Identifier:

NCT01597362

Other Study ID Numbers:

TRC-01

First Posted:

May 14, 2012

Last Update Posted:

May 14, 2012

Last Verified:

May 1, 2012

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

Study Results

No Results Posted as of May 14, 2012