Pheochromocytoma Clinical Trial
Official title:
Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study
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.
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. |
Country | Name | City | State |
---|---|---|---|
Czechia | University hospital Olomouc | Olomouc |
Lead Sponsor | Collaborator |
---|---|
University Hospital Olomouc | General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Hradec Kralove, University Hospital Ostrava |
Czechia,
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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