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

Pheochromocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050057
• Other study ID #: FNOL 122/23
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenoma
• Adrenal Cortex Diseases
• Adrenal Cortex Neoplasms
• Adrenal Disease
• Adrenal Gland Diseases
• Adrenal Gland Neoplasms
• Adrenal Hyperplasia
• Adrenal Hyperplasia, Congenital
• Adrenal Mass
• Adrenal Tumor
• Adrenalectomy; Status
• Adrenocortical Adenoma
• Adrenocortical Carcinoma
• Adrenocortical Tumor
• Adrenogenital Syndrome
• Conn Adenoma
• Cushing Syndrome
• Hyperplasia
• Pheochromocytoma

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