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

NCT ID: NCT06050057

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-03

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role collaborator

Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role collaborator

General University Hospital, Prague

OTHER

Sponsor Role collaborator

University Hospital Hradec Kralove

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role lead

Responsible Party

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Natalia Wiesner

Head of the urological clinic, MUDr. Igor Hartmann Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MUDr. Igor Hartmann Ph.D.

Role: STUDY_CHAIR

Dpt. of Urology, University hospital Olomouc

Locations

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University hospital Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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MUDr. Igor Hartmann Ph.D.

Role: CONTACT

+420588442895

Natalia Wiesner

Role: CONTACT

+420588445709

Facility Contacts

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Igor Hartmqnn, MD, PhD

Role: primary

+420588442895

Other Identifiers

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FNOL 122/23

Identifier Type: -

Identifier Source: org_study_id

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