3D Laparoscopic Adrenalectomies for Adrenal Tumors

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status: Enrolling

Conditions: Adrenal Tumor; Adrenalectomy; Status

Study type: Observational

Funder types: Other

Identifiers

NCT04905706

2020.141

Details and patient eligibility

About

The main drawbacks of conventional 2D laparoscopy are limited depth perception and loss of spatial orientation. High-quality 3D laparoscopy systems might improve surgical outcomes for adrenalectomy.

Full description

Over recent decades, technological advances such as improved video imaging (high-definition cameras), better instrumentation for dissection and hemostasis, articulating staplers, and optimized operating room lighting have added safety, efficacy, and precision to minimally invasive procedures. However, until recently, laparoscopy required surgeons to operate in a three-dimensional (3D) space with only two-dimensional (2D) images to guide their movements, resulting in a lack of depth perception and loss of spatial orientation that increased the risk of errors, fatigue, operative time, and operating room stress and made the technique difficult to learn.

High-quality 3D laparoscopy was developed as an alternative to conventional 2D laparoscopy. Several clinical trials and observational studies have compared surgical outcomes between 2D and 3D laparoscopic systems; however, few clinical studies have examined the usefulness of 3D laparoscopy systems for adrenalectomies.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients (age ≥ 18 years)
• Patients diagnosed with adrenal masses (benign and malignant tumors)
• Underwent a unilateral 3D laparoscopic adrenalectomy from January 2013 to December 2033.

Exclusion criteria

• Emergency surgery.
• Open adrenalectomy.
• Bilateral adrenalectomies (open or laparoscopy).
• Patients who underwent laparoscopic adrenalectomy together with another laparoscopic surgical procedure in the same intervention.
• Patients without complete follow-up for at least 30 days after hospital discharge.

Trial design

300 participants in 1 patient group

3D laparoscopic adrenalectomy

Description:

Operations are done with an high definition 3D laparoscopic system (Olympus, Tokyo, Japan); all personnel wear polarized glasses to achieve stereoscopic imaging in the operating room. Dissection is realized using a hybrid energy system (Thunderbeat, Olympus Europe Se \& Co, Hamburg, Germany).