Three Laparoscopic Access Techniques

Campus Bio-Medico University of Rome

Status: Completed

Conditions: Benign Gynecological Pathology

Treatments: Procedure: Laparoscopy; Procedure: laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01597362

TRC-01

Details and patient eligibility

About

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.

Enrollment: 608 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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608 participants in 3 patient groups

Veress needle technique

Other group

Treatment:

Procedure: Laparoscopy

Procedure: Laparoscopy

Procedure: Laparoscopy

Direct trocar technique

Other group

Treatment:

Procedure: Laparoscopy

Procedure: Laparoscopy

Procedure: Laparoscopy

Open technique

Other group

Treatment:

Procedure: laparoscopy