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

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenal Tumor, Pheochromocytoma, Conn Adenoma, Cushing Syndrome, Adrenalectomy, Laparoscopic surgery, da Vinci surgical system