3D Laparoscopic Adrenalectomies for Adrenal Tumors

NCT ID: NCT04905706

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adrenal Tumor Adrenalectomy; Status

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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3D laparoscopic adrenalectomy

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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role lead

Responsible Party

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José Ignacio Rodríguez-Hermosa

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitari Dr. Josep Trueta de Girona

Girona, Girona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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José Ignacio Rodríguez-Hermosa, MD, PhD

Role: CONTACT

+34 972 94 02 56

Facility Contacts

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José Ignacio Rodríguez-Hermosa, MD, PhD

Role: primary

972940256

Other Identifiers

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2020.141

Identifier Type: -

Identifier Source: org_study_id

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