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

NCT06050057 | Recruiting

• 1 other identifier: FNOL 122/23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.to find the superiority of one the the surgical method mentioned above
2. 2.to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

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

Outcome Measures

Primary Outcomes (19)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Indicated adrenalectomy based on endocrinological and imaging examination.
• Written consent to participate in the study.

You may not qualify if:

• Simultaneous bilateral adrenalectomy.
• Adrenal expansion \> 12 cm.
• Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.

Sponsors & Collaborators

• University Hospital Olomouc: lead
• University Hospital Ostrava: collaborator
• Tomas Bata Hospital, Czech Republic: collaborator
• General University Hospital, Prague: collaborator
• University Hospital Hradec Kralove: collaborator

Study Sites (1)

University hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

MeSH Terms

Conditions

Adrenal Gland Neoplasms; Adrenal Gland Diseases; Adrenal Hyperplasia, Congenital; Adrenal Cortex Diseases; Pheochromocytoma; Cushing Syndrome; Adrenocortical Adenoma; Adrenocortical Carcinoma; Adrenal Cortex Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Endocrine System Diseases; Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Gonadal Disorders; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adrenocortical Hyperfunction; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• MUDr. Igor Hartmann Ph.D.

  Dpt. of Urology, University hospital Olomouc

  STUDY CHAIR

Central Study Contacts

MUDr. Igor Hartmann Ph.D.

CONTACT

+420588442895; Igor.Hartmann@fnol.cz

Natalia Wiesner

CONTACT

+420588445709; natalia.wiesner@fnol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the urological clinic, MUDr. Igor Hartmann Ph.D.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 22, 2023
• Study Start: September 3, 2023
• Primary Completion: June 30, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

CZ (1)