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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06050057
Other study ID # FNOL 122/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 3, 2023
Est. completion date June 30, 2026

Study information

Verified date September 2023
Source University Hospital Olomouc
Contact MUDr. Igor Hartmann Ph.D.
Phone +420588442895
Email Igor.Hartmann@fnol.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2026
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Czechia University hospital Olomouc Olomouc

Sponsors (5)

Lead Sponsor Collaborator
University Hospital Olomouc General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Hradec Kralove, University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initial examination 1 Initial examination by a urologist and indication for the surgery. 1 day
Primary Initial examination 2 Sampling of biological material: Hemoglobin g/l 1 day
Primary Surgical period 1 Measuring the operation time in minutes. 1 day
Primary Surgical period 2 Measuring the blood loss in milliliters (ml). 1 day
Primary Surgical period 3 Record the need for conversion to open surgery. 1 day
Primary Surgical period 4 Record the surgical complications. 1 day
Primary Surgical period 5 The consumption of special surgical instruments. 1 day
Primary Perioperative period 1 Perioperatively, the length of stay in the ICU in days. from 3- 7 days
Primary Perioperative period 2 Perioperatively, total hospitalization time in days from 3- 7 days
Primary Perioperative period 3 Perioperatively, blood loss from the drain in mililiters (ml). from 3- 7 days
Primary Perioperative period 4 Perioperatively, time to remove the abdominal drain in days. from 3- 7 days
Primary Perioperative period 5 Perioperatively, need for blood substitutes. from 3- 7 days
Primary Perioperative period 6 Perioperatively, number of forced surgical revisions. from 3- 7 days
Primary Perioperative period 7 Perioperatively, consumption of analgesics during the hospitalization. from 3- 7 days
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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