Three Laparoscopic Access Techniques
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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 More Information
No publications provided
| 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 May 22, 2013