3D Laparoscopic Adrenalectomies for Adrenal Tumors

Study Overview
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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.

Official Title
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Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors

Conditions
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Adrenal Tumor, Adrenalectomy; Status

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3D laparoscopic adrenalectomy<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications rate of 3D laparoscopic adrenalectomy | 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. | Within 30 days after surgery | 
| Length of hospital stay | Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) . | Up to 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Three-dimensional laparoscopy, Adrenal tumors, 3D laparoscopic adrenalectomy