Clinical trial NCT06050057: Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Official title: Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Adrenal Tumor
Pheochromocytoma
Conn Adenoma
Cushing Syndrome
Adrenalectomy
Laparoscopic surgery
da Vinci surgical system
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: University Hospital Ostrava
name: Tomas Bata Hospital, Czech Republic
name: General University Hospital, Prague
name: University Hospital Hradec Kralove
First posted: 2023-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for adrenalectomy based on endocrinological and imaging examination. All patients older than 18 years who met the clinical criteria.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Initial examination 1
timeFrame: 1 day
measure: Initial examination 2
timeFrame: 1 day
measure: Surgical period 1
timeFrame: 1 day
measure: Surgical period 2
timeFrame: 1 day
measure: Surgical period 3
timeFrame: 1 day
measure: Surgical period 4
timeFrame: 1 day
measure: Surgical period 5
timeFrame: 1 day
measure: Perioperative period 1
timeFrame: from 3- 7 days
measure: Perioperative period 2
timeFrame: from 3- 7 days
measure: Perioperative period 3
timeFrame: from 3- 7 days
measure: Perioperative period 4
timeFrame: from 3- 7 days
measure: Perioperative period 5
timeFrame: from 3- 7 days
measure: Perioperative period 6
timeFrame: from 3- 7 days
measure: Perioperative period 7
timeFrame: from 3- 7 days
measure: First post-operative check-up 1
timeFrame: 1 day of examination, 14- 20 days from the surgery
measure: First post-operative check-up 2
timeFrame: 1 day of examination, 14- 20 days from the surgery
measure: First post-operative check-up 3
timeFrame: 1 day of examination, 14- 20 days from the surgery
measure: Second post-operative check-up 1
timeFrame: 1 day of examination, 85-100 days from the surgery
measure: Second post-operative check-up 2
timeFrame: 1 day of examination, 85-100 days from the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University hospital Olomouc
Study officials:
affiliation: Dpt. of Urology, University hospital Olomouc
name: MUDr. Igor Hartmann Ph.D.
role: STUDY_CHAIR
References: