Actively Recruiting

Age: 18Years +
All Genders
ID06050057

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indicated adrenalectomy based on endocrinological and imaging examination.
  • Written consent to participate in the study.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 to 2 visits depending on initial examinations

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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

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