Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06050057 - Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Completed NCT06330558 - Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma.
Completed NCT04071561 - Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions
Recruiting NCT06229405 - Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
Completed NCT00454103 - Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy Phase 1/Phase 2
Completed NCT03469102 - 18FDG PET Textural Indices in Adrenal Lesion
Completed NCT01959711 - Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy Phase 4
Recruiting NCT04127552 - Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
Completed NCT03830593 - Laparoscopic Adrenalectomy for Large Adrenal Tumors.
Recruiting NCT05739812 - The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery N/A
Completed NCT03739918 - Rare Cystic Benign Adrenal Incidentalomas
Completed NCT04804163 - Research on the Effectiveness and Safety of Remote Control of Domestic Surgical Robot System for Urinary Surgery Early Phase 1
Completed NCT03327142 - EUS-guided FNA in the Study of the Adrenal Gland N/A
Completed NCT04570176 - Efficacy and Safety of Clinical Telesurgery Using Chinese Independently Developed Surgical Robot System N/A
Not yet recruiting NCT04432532 - Neuroendocrine and Adrenal Tumors