Actively Recruiting
Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study
Led by University Hospital Olomouc · Updated on 2023-09-22
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University Hospital Olomouc
Lead Sponsor
U
University Hospital Ostrava
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical methods, laparoscopic and robot-assisted adrenalectomy, to treat patients with adrenal diseases. This multicenter, observational, analytic, randomized clinical trial aims to determine which surgical method may be superior and to compare the quality of life in patients before and after surgery for adrenal masses. The study focuses on various adrenal conditions including adrenal tumors, hyperplasia, and syndromes such as Cushing and Conn adenoma. Participants undergo either laparoscopic or robotic-assisted adrenalectomy based on medical indications, with the study observing and analyzing outcomes related to these two surgical approaches. The study includes initial examinations, multiple surgical and perioperative assessments conducted over a period of days, and follow-up check-ups occurring from 14 to 100 days after surgery. No investigational drugs or additional treatments are involved. During the study, participants will have several examinations and evaluations including imaging and endocrinological tests before surgery, closely monitored surgical and perioperative periods, and post-operative visits to assess recovery and quality of life. Researchers will track outcomes related to surgery and quality of life changes after the procedure. The total observation includes early post-operative follow-ups and a later check-up approximately three months after surgery, providing detailed monitoring throughout the surgical and recovery process.
CONDITIONS
Brief Title
Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indicated adrenalectomy based on endocrinological and imaging examination.
- Written consent to participate in the study.
You will not qualify if you...
- Simultaneous bilateral adrenalectomy.
- Adrenal expansion > 12 cm.
- Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits depending on initial examinations
Duration - 1 day for surgery and 3 to 7 days for perioperative care
Participants undergo laparoscopic or robotic-assisted adrenalectomy and receive immediate post-surgery care during the perioperative period.
1 day of surgery and daily visits for 3 to 7 days post-surgery
Duration - Up to 100 days after surgery
Participants attend follow-up visits to monitor recovery and outcomes after surgery.
3 visits between 14 to 20 days and 2 visits between 85 to 100 days after surgery
Trial Site Locations
Total: 1 location
1
University hospital Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
Research Team
M
MUDr. Igor Hartmann Ph.D.
N
Natalia Wiesner
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here