Three Laparoscopic Access Techniques

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.

Study Overview

• Status: Completed
• Conditions: Benign Gynecological Pathology
• Intervention / Treatment: Procedure: Laparoscopy; Procedure: Laparoscopy; Procedure: Laparoscopy; Procedure: laparoscopy

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.; 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.
OTHER: Direct trocar 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.; 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.
OTHER: Open technique	Procedure: laparoscopy; Trocar access in laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
minor complications	feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications	1 year

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Publications and helpful links

General Publications

• Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 11, 2012
• First Posted (ESTIMATE): May 14, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 11, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: laparoscopy; open; direct; trocars; veress
• Other Study ID Numbers: TRC-01