3D Laparoscopic Adrenalectomies for Adrenal Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adrenal Tumor, Adrenalectomy; Status. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
Overview
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.
Primary outcome measures
- Postoperative complications rate of 3D laparoscopic adrenalectomy [Time frame: Within 30 days after surgery]
- Length of hospital stay [Time frame: Up to 4 weeks]
Secondary outcome measures (12)
- Conversion rate trough 3D laparoscopic adrenalectomy [Time frame: Intraoperatively]
- Intraoperative bleeding during 3D laparoscopic adrenalectomy [Time frame: Intraoperatively]
- Operative time trough 3D laparoscopic adrenalectomy [Time frame: Intraoperatively]
- Routine use of abdominal drainage in 3D laparoscopic adrenalectomy [Time frame: Intraoperatively]
- Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system [Time frame: Within 30 days after surgery]
- Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system [Time frame: Within 30 days after surgery]
- Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system [Time frame: Within 30 days after surgery]
- 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]
- Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system [Time frame: Within 30 days after surgery]
- Comparison of adrenal mass diagnosis operated by 3D laparoscopic system [Time frame: Within 30 days after surgery]
- Comparison of adrenal mass laterality operated by 3D laparoscopic system [Time frame: Within 30 days after surgery]
- Comparison of morbidity between 2D versus 3D laparoscopic system [Time frame: Within 30 days after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Universitari Dr. Josep Trueta de Girona — Girona
Identifiers
NCT: NCT04905706 · 2020.141