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

Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cushing Syndrome; Pheochromocytoma; Adrenocortical Carcinoma; Adrenal Cortex Diseases; Adrenocortical Adenoma; Adrenal Tumor; Adrenalectomy; Status; Adrenal Mass; Adrenal Hyperplasia; Adrenal Disease; Adrenocortical Tumor; Conn Adenoma; Adrenal Gland Metastasis

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: MUDr. Igor Hartmann Ph.D.; Phone Number: +420588442895; Email: Igor.Hartmann@fnol.cz
• Study Contact Backup: Name: Natalia Wiesner; Phone Number: +420588445709; Email: natalia.wiesner@fnol.cz

Study Locations

• Czechia
  • Olomouc, Czechia, 77900
    • Recruiting
    • University Hospital Olomouc
    • Contact: Igor Hartmqnn, MD, PhD; Phone Number: +420588442895; Email: igor.hartmann@fnol.cz
    • Principal Investigator: Natalia Wiesner, MD
    • Principal Investigator: Igor Hartmann, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial examination 1	Initial examination by a urologist and indication for the surgery.	1 day
Initial examination 2	Sampling of biological material: Hemoglobin g/l	1 day
Surgical period 1	Measuring the operation time in minutes.	1 day
Surgical period 2	Measuring the blood loss in milliliters (ml).	1 day
Surgical period 3	Record the need for conversion to open surgery.	1 day
Surgical period 4	Record the surgical complications.	1 day
Surgical period 5	The consumption of special surgical instruments.	1 day
Perioperative period 1	Perioperatively, the length of stay in the ICU in days.	from 3- 7 days
Perioperative period 2	Perioperatively, total hospitalization time in days	from 3- 7 days
Perioperative period 3	Perioperatively, blood loss from the drain in mililiters (ml).	from 3- 7 days
Perioperative period 4	Perioperatively, time to remove the abdominal drain in days.	from 3- 7 days
Perioperative period 5	Perioperatively, need for blood substitutes.	from 3- 7 days
Perioperative period 6	Perioperatively, number of forced surgical revisions.	from 3- 7 days
Perioperative period 7	Perioperatively, consumption of analgesics during the hospitalization.	from 3- 7 days
First post-operative check-up 1	First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l	1 day of examination, 14- 20 days from the surgery
First post-operative check-up 2	First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification	1 day of examination, 14- 20 days from the surgery
First post-operative check-up 3	First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.	1 day of examination, 14- 20 days from the surgery
Second post-operative check-up 1	Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.	1 day of examination, 85-100 days from the surgery
Second post-operative check-up 2	Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions	1 day of examination, 85-100 days from the surgery

Collaborators and Investigators

• Sponsor: University Hospital Olomouc
• Collaborators: University Hospital Ostrava; Tomas Bata Hospital, Czech Republic; General University Hospital, Prague; University Hospital Hradec Kralove
• Investigators: Study Chair: MUDr. Igor Hartmann Ph.D., Dpt. of Urology, University hospital Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Pheochromocytoma; Cushing Syndrome; Adrenalectomy; da Vinci surgical system; Adrenal Tumor; Conn Adenoma
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Endocrine Gland Neoplasms; Genetic Diseases, Inborn; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Metabolism, Inborn Errors; Neuroendocrine Tumors; Adrenocortical Hyperfunction; Steroid Metabolism, Inborn Errors; Paraganglioma; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Adenoma; Hyperplasia; Cushing Syndrome; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Pheochromocytoma; Adrenocortical Carcinoma; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenocortical Adenoma; Adrenal Gland Diseases; Adrenal Cortex Neoplasms
• Other Study ID Numbers: FNOL 122/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No