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

Sponsor

University Hospital Olomouc (Other)

Overall Status

Recruiting

CT.gov ID

NCT06050057

Collaborator

University Hospital Ostrava (Other), Tomas Bata Hospital, Czech Republic (Other), General University Hospital, Prague (Other), University Hospital Hradec Kralove (Other)

100

Enrollment

Location

33.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
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

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 3, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2026

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.