Adrenal Cortex Diseases, Adrenal Disease, Adrenalectomy; Status, Adrenal Gland Metastasis, Adrenal Hyperplasia, Adrenal Mass, Adrenal Tumor, Adrenocortical Adenoma, Adrenocortical Carcinoma, Adrenocortical Tumor, Conn Adenoma, Cushing Syndrome, Pheochromocytoma
Conditions
Keywords
Adrenal Tumor, Pheochromocytoma, Conn Adenoma, Cushing Syndrome, Adrenalectomy, Laparoscopic surgery, da Vinci surgical system
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.
Interventions
None listed
Sponsors
University Hospital Ostrava
Tomas Bata Hospital, Czech Republic
General University Hospital, Prague
University Hospital Hradec Kralove
University Hospital Olomouc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Czechia
Contacts
Primary ContactMUDr. Igor Hartmann Ph.D.
Backup ContactNatalia Wiesner
Outcome results
None listed