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

Recruiting

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

• Registration Number: NCT06050057
• Lead Sponsor: University Hospital Olomouc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-03
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-17
• Last Update Submitted: 2023-09-17
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University hospital Olomouc; 🇨🇿 Olomouc, Czechia