Clinical trial NCT04905706: 3D Laparoscopic Adrenalectomies for Adrenal Tumors
Official title: Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Tumor
Adrenalectomy; Status
Keywords: Three-dimensional laparoscopy
Adrenal tumors
3D laparoscopic adrenalectomy
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients (age ≥ 18 years) who underwent a unilateral 3D laparoscopic adrenalectomy for adrenal masses (benign and malignant tumors) from January 2013 to December 2033.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications rate of 3D laparoscopic adrenalectomy
timeFrame: Within 30 days after surgery
measure: Length of hospital stay
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Conversion rate trough 3D laparoscopic adrenalectomy
timeFrame: Intraoperatively
measure: Intraoperative bleeding during 3D laparoscopic adrenalectomy
timeFrame: Intraoperatively
measure: Operative time trough 3D laparoscopic adrenalectomy
timeFrame: Intraoperatively
measure: Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
timeFrame: Intraoperatively
measure: Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of morbidity between American Society of Anesthesiologists I+II and III+IV operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of adrenal mass diagnosis operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of adrenal mass laterality operated by 3D laparoscopic system
timeFrame: Within 30 days after surgery
measure: Comparison of morbidity between 2D versus 3D laparoscopic system
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta de Girona
Study officials:
References: