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NCT Number: NCT04905706

3D Laparoscopic Adrenalectomies for Adrenal Tumors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Dr. Josep Trueta de Girona

Girona, 17007, Spain

Location status: Recruiting

Location contact

José Ignacio Rodríguez-Hermosa, MD, PhD

CONTACT

[email protected]

972940256

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postoperative complications rate of 3D laparoscopic adrenalectomy

    Time frame: Within 30 days after surgery

    Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as:

    Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

    Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.

  2. Length of hospital stay

    Time frame: Up to 4 weeks

    Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .

Secondary outcomes

  1. Conversion rate trough 3D laparoscopic adrenalectomy

    Time frame: Intraoperatively

    Conversion to open surgery (Yes vs No).

  2. Intraoperative bleeding during 3D laparoscopic adrenalectomy

    Time frame: Intraoperatively

    Blood loss during surgery (millilitres)

  3. Operative time trough 3D laparoscopic adrenalectomy

    Time frame: Intraoperatively

    Duration of intervention (minutes)

  4. Routine use of abdominal drainage in 3D laparoscopic adrenalectomy

    Time frame: Intraoperatively

    Use of abdominal drainage intraoperatively (Yes vs No).

  5. Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    No obese: <30 kg/m2 Obese: ≥30 kg/m2

  6. Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    Prior abdominal surgery (Yes vs No).

  7. Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    Young <65 years, Elderly ≥65 years

  8. Comparison of morbidity between American Society of Anesthesiologists I+II and III+IV operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

  9. Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    Adrenal mass <6 cm, Adrenal mass ≥6 cm

  10. Comparison of adrenal mass diagnosis operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)

  11. Comparison of adrenal mass laterality operated by 3D laparoscopic system

    Time frame: Within 30 days after surgery

    Right adrenal mass, left adrenal mass

  12. Comparison of morbidity between 2D versus 3D laparoscopic system

    Time frame: Within 30 days after surgery

    Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification

Study contacts

Contact information is provided by the study sponsor or research team.

José Ignacio Rodríguez-Hermosa, MD, PhD

CONTACT

[email protected]

+34 972 94 02 56

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors

Important dates

Study start
2013
Primary completion
2033
Study completion
2033
First posted
May 28, 2021
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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