Adrenal Tumor Clinical Trial
Official title:
Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
NCT number | NCT04905706 |
Other study ID # | 2020.141 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2013 |
Est. completion date | December 31, 2033 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2033 |
Est. primary completion date | November 30, 2033 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Dr. Josep Trueta de Girona | Girona |
Lead Sponsor | Collaborator |
---|---|
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Conversion rate trough 3D laparoscopic adrenalectomy | Conversion to open surgery (Yes vs No). | Intraoperatively | |
Secondary | Intraoperative bleeding during 3D laparoscopic adrenalectomy | Blood loss during surgery (millilitres) | Intraoperatively | |
Secondary | Operative time trough 3D laparoscopic adrenalectomy | Duration of intervention (minutes) | Intraoperatively | |
Secondary | Routine use of abdominal drainage in 3D laparoscopic adrenalectomy | Use of abdominal drainage intraoperatively (Yes vs No). | Intraoperatively | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system | Young <65 years, Elderly =65 years | Within 30 days after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Comparison of adrenal mass laterality operated by 3D laparoscopic system | Right adrenal mass, left adrenal mass | Within 30 days after surgery | |
Secondary | 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 |
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