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RecruitingNCT06050057Updated Sep 22, 2023

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

An observational study in Adrenal Tumor, Adrenal Disease and Adrenal Mass, sponsored by University Hospital Olomouc. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by University Hospital Olomouc · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • 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
03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

University Hospital Olomouc is the lead sponsor of 40 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Simultaneous bilateral adrenalectomy.
  • Adrenal expansion > 12 cm.
  • Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Initial examination 1

    Initial examination by a urologist and indication for the surgery.

    Time frame: 1 day

  2. Initial examination 2

    Sampling of biological material: Hemoglobin g/l

    Time frame: 1 day

  3. Surgical period 1

    Measuring the operation time in minutes.

    Time frame: 1 day

  4. Surgical period 2

    Measuring the blood loss in milliliters (ml).

    Time frame: 1 day

  5. Surgical period 3

    Record the need for conversion to open surgery.

    Time frame: 1 day

  6. Surgical period 4

    Record the surgical complications.

    Time frame: 1 day

  7. Surgical period 5

    The consumption of special surgical instruments.

    Time frame: 1 day

  8. Perioperative period 1

    Perioperatively, the length of stay in the ICU in days.

    Time frame: from 3- 7 days

  9. Perioperative period 2

    Perioperatively, total hospitalization time in days

    Time frame: from 3- 7 days

  10. Perioperative period 3

    Perioperatively, blood loss from the drain in mililiters (ml).

    Time frame: from 3- 7 days

  11. Perioperative period 4

    Perioperatively, time to remove the abdominal drain in days.

    Time frame: from 3- 7 days

  12. Perioperative period 5

    Perioperatively, need for blood substitutes.

    Time frame: from 3- 7 days

  13. Perioperative period 6

    Perioperatively, number of forced surgical revisions.

    Time frame: from 3- 7 days

  14. Perioperative period 7

    Perioperatively, consumption of analgesics during the hospitalization.

    Time frame: from 3- 7 days

  15. First post-operative check-up 1

    First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l

    Time frame: 1 day of examination, 14- 20 days from the surgery

  16. 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

    Time frame: 1 day of examination, 14- 20 days from the surgery

  17. First post-operative check-up 3

    First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.

    Time frame: 1 day of examination, 14- 20 days from the surgery

  18. 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.

    Time frame: 1 day of examination, 85-100 days from the surgery

  19. Second post-operative check-up 2

    Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions

    Time frame: 1 day of examination, 85-100 days from the surgery

07

Study locations

1 of 1 sites recruiting
  • University hospital Olomouc
    Olomouc, 77900, Czechia
    • Igor Hartmqnn, MD, PhD · Contact · igor.hartmann@fnol.cz · +420588442895
    • Natalia Wiesner, MD · Principal investigator
    • Igor Hartmann, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06050057
Lead sponsor
University Hospital Olomouc
Collaborators
University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, General University Hospital, Prague, University Hospital Hradec Kralove
Responsible party
Natalia Wiesner (Head of the urological clinic, MUDr. Igor Hartmann Ph.D., University Hospital Olomouc) — Principal investigator
First posted
Sep 22, 2023
Start date
Sep 3, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 22, 2023

Study contacts

MUDr. Igor Hartmann Ph.D.
Contact
Igor.Hartmann@fnol.cz
+420588442895
Natalia Wiesner
Contact
natalia.wiesner@fnol.cz
+420588445709
MUDr. Igor Hartmann Ph.D.
study chair · Dpt. of Urology, University hospital Olomouc

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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