Three Laparoscopic Access Techniques

NCT ID: NCT01597362

Last Updated: 2012-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Benign Gynecological Pathology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Veress needle technique

Group Type: OTHER

Laparoscopy

Intervention Type: PROCEDURE

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

Group Type: OTHER

Laparoscopy

Intervention Type: PROCEDURE

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

Group Type: OTHER

laparoscopy

Intervention Type: PROCEDURE

Trocar access in laparoscopy

Laparoscopy

Intervention Type: PROCEDURE

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.

Interventions

laparoscopy

Trocar access in laparoscopy

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Cafa Ester Valentina

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 24103531 (View on PubMed)

Other Identifiers

TRC-01

Identifier Type: -

Identifier Source: org_study_id