3D Laparoscopic Adrenalectomies for Adrenal Tumors

Recruiting

• Conditions: Adrenalectomy; Status; Adrenal Tumor

• Registration Number: NCT04905706
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2033-11-30
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications rate of 3D laparoscopic adrenalectomy	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.
Length of hospital stay	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 Outcome Measures

Name	Time	Method
Conversion rate trough 3D laparoscopic adrenalectomy	Intraoperatively	Conversion to open surgery (Yes vs No).
Routine use of abdominal drainage in 3D laparoscopic adrenalectomy	Intraoperatively	Use of abdominal drainage intraoperatively (Yes vs No).
Comparison of adrenal mass diagnosis operated by 3D laparoscopic system	Within 30 days after surgery	Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)
Comparison of adrenal mass laterality operated by 3D laparoscopic system	Within 30 days after surgery	Right adrenal mass, left adrenal mass
Intraoperative bleeding during 3D laparoscopic adrenalectomy	Intraoperatively	Blood loss during surgery (millilitres)
Operative time trough 3D laparoscopic adrenalectomy	Intraoperatively	Duration of intervention (minutes)
Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system	Within 30 days after surgery	Young \<65 years, Elderly ≥65 years
Comparison of morbidity between 2D versus 3D laparoscopic system	Within 30 days after surgery	Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification
Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system	Within 30 days after surgery	No obese: \<30 kg/m2 Obese: ≥30 kg/m2
Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system	Within 30 days after surgery	Prior abdominal surgery (Yes vs No).
Comparison of morbidity between American Society of Anesthesiologists I+II and III+IV operated by 3D laparoscopic system	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
Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system	Within 30 days after surgery	Adrenal mass \<6 cm, Adrenal mass ≥6 cm

Trial Locations

Locations (1)

Hospital Universitari Dr. Josep Trueta de Girona; 🇪🇸 Girona, Spain