3D Laparoscopic Adrenalectomies for Adrenal Tumors

Adrenal Tumor Clinical Trial

Official title:

Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905706
• Other study ID #: 2020.141
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2033

Study information

• Verified date: March 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: José Ignacio Rodríguez-Hermosa, MD, PhD
• Phone: +34 972 94 02 56
• Email: jirodriguez.girona.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Tumor
• Adrenalectomy; Status

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr. Josep Trueta de Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

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