Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Surgical period 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicated adrenalectomy based on endocrinological and imaging examination.
- •Written consent to participate in the study.
排除标准
- •Simultaneous bilateral adrenalectomy.
- •Adrenal expansion > 12 cm.
- •Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.
结局指标
主要结局
Surgical period 2
时间窗: 1 day
Measuring the blood loss in milliliters (ml).
Perioperative period 1
时间窗: from 3- 7 days
Perioperatively, the length of stay in the ICU in days.
Perioperative period 3
时间窗: from 3- 7 days
Perioperatively, blood loss from the drain in mililiters (ml).
Surgical period 1
时间窗: 1 day
Measuring the operation time in minutes.
Initial examination 1
时间窗: 1 day
Initial examination by a urologist and indication for the surgery.
Surgical period 4
时间窗: 1 day
Record the surgical complications.
Perioperative period 6
时间窗: from 3- 7 days
Perioperatively, number of forced surgical revisions.
Second post-operative check-up 1
时间窗: 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
时间窗: 1 day of examination, 85-100 days from the surgery
Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions
Initial examination 2
时间窗: 1 day
Sampling of biological material: Hemoglobin g/l
Surgical period 3
时间窗: 1 day
Record the need for conversion to open surgery.
Surgical period 5
时间窗: 1 day
The consumption of special surgical instruments.
Perioperative period 2
时间窗: from 3- 7 days
Perioperatively, total hospitalization time in days
Perioperative period 4
时间窗: from 3- 7 days
Perioperatively, time to remove the abdominal drain in days.
Perioperative period 7
时间窗: from 3- 7 days
Perioperatively, consumption of analgesics during the hospitalization.
Perioperative period 5
时间窗: from 3- 7 days
Perioperatively, need for blood substitutes.
First post-operative check-up 1
时间窗: 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
时间窗: 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
时间窗: 1 day of examination, 14- 20 days from the surgery
First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.
次要结局
未报告次要终点
研究者
Natalia Wiesner
Head of the urological clinic, MUDr. Igor Hartmann Ph.D.
University Hospital Olomouc