Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy

Study Purpose

The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are: 1. to find the superiority of one the the surgical method mentioned above. 2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Indicated adrenalectomy based on endocrinological and imaging examination.
  • - Written consent to participate in the study.

Exclusion Criteria:

  • - Simultaneous bilateral adrenalectomy.
  • - Adrenal expansion > 12 cm.
  • - Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06050057
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Olomouc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MUDr. Igor Hartmann Ph.D.
Principal Investigator Affiliation Dpt. of Urology, University hospital Olomouc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Czechia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adrenal Tumor, Adrenal Disease, Adrenal Mass, Adrenalectomy; Status, Adrenal Hyperplasia, Adrenal Gland Metastasis, Adrenal Cortex Diseases, Pheochromocytoma, Cushing Syndrome, Conn Adenoma, Adrenocortical Carcinoma, Adrenocortical Adenoma, Adrenocortical Tumor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University hospital Olomouc, Olomouc, Czechia

Status

Recruiting

Address

University hospital Olomouc

Olomouc, , 77900

Site Contact

Igor Hartmqnn, MD, PhD

igor.hartmann@fnol.cz

+420588442895

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