- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905706
3D Laparoscopic Adrenalectomies for Adrenal Tumors
Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: José Ignacio Rodríguez-Hermosa, MD, PhD
- Phone Number: +34 972 94 02 56
- Email: jirodriguez.girona.ics@gencat.cat
Study Locations
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Girona, Spain, 17007
- Recruiting
- Hospital Universitari Dr. Josep Trueta de Girona
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Contact:
- José Ignacio Rodríguez-Hermosa, MD, PhD
- Phone Number: 972940256
- Email: jirodriguez.girona.ics@gencat.cat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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3D laparoscopic adrenalectomy
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications rate of 3D laparoscopic adrenalectomy
Time Frame: Within 30 days after surgery
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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
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Length of hospital stay
Time Frame: Up to 4 weeks
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Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .
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Up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion rate trough 3D laparoscopic adrenalectomy
Time Frame: Intraoperatively
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Conversion to open surgery (Yes vs No).
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Intraoperatively
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Intraoperative bleeding during 3D laparoscopic adrenalectomy
Time Frame: Intraoperatively
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Blood loss during surgery (millilitres)
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Intraoperatively
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Operative time trough 3D laparoscopic adrenalectomy
Time Frame: Intraoperatively
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Duration of intervention (minutes)
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Intraoperatively
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Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
Time Frame: Intraoperatively
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Use of abdominal drainage intraoperatively (Yes vs No).
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Intraoperatively
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Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system
Time Frame: Within 30 days after surgery
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No obese: <30 kg/m2 Obese: ≥30 kg/m2
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Within 30 days after surgery
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Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system
Time Frame: Within 30 days after surgery
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Prior abdominal surgery (Yes vs No).
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Within 30 days after surgery
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Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system
Time Frame: Within 30 days after surgery
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Young <65 years, Elderly ≥65 years
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Within 30 days after surgery
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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
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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
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Within 30 days after surgery
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Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system
Time Frame: Within 30 days after surgery
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Adrenal mass <6 cm, Adrenal mass ≥6 cm
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Within 30 days after surgery
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Comparison of adrenal mass diagnosis operated by 3D laparoscopic system
Time Frame: Within 30 days after surgery
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Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)
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Within 30 days after surgery
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Comparison of adrenal mass laterality operated by 3D laparoscopic system
Time Frame: Within 30 days after surgery
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Right adrenal mass, left adrenal mass
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Within 30 days after surgery
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Comparison of morbidity between 2D versus 3D laparoscopic system
Time Frame: Within 30 days after surgery
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Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification
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Within 30 days after surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020.141
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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