Hospital Universitari Dr. Josep Trueta de Girona
Girona, 17007, Spain
Location status: Recruiting
NCT Number: NCT04905706
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Girona, 17007, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Up to 4 weeks
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .
Time frame: Intraoperatively
Conversion to open surgery (Yes vs No).
Time frame: Intraoperatively
Blood loss during surgery (millilitres)
Time frame: Intraoperatively
Duration of intervention (minutes)
Time frame: Intraoperatively
Use of abdominal drainage intraoperatively (Yes vs No).
Time frame: Within 30 days after surgery
No obese: <30 kg/m2 Obese: ≥30 kg/m2
Time frame: Within 30 days after surgery
Prior abdominal surgery (Yes vs No).
Time frame: Within 30 days after surgery
Young <65 years, Elderly ≥65 years
Time frame: 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
Time frame: Within 30 days after surgery
Adrenal mass <6 cm, Adrenal mass ≥6 cm
Time frame: Within 30 days after surgery
Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)
Time frame: Within 30 days after surgery
Right adrenal mass, left adrenal mass
Time frame: Within 30 days after surgery
Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification
Contact information is provided by the study sponsor or research team.
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Other
Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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