Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy (NCT01676025) | Clinical Trial Compass
CompletedNot Applicable
Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy
South Korea83 participantsStarted 2012-09
Plain-language summary
The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are expected to have benign adrenal disease at preoperative exams
* Patients who have pheochromocytoma measured less than 5cm, and the other benign adrenal tumors less than 7cm in diameter in preoperative CT scan
* Patients who do not have previous surgery history at the interested quadrant
* Patients who is I or II grade in ASA classification(American society of anesthesiologists' physical status classification)
* Patients who has tolerable liver function and renal function(bilirubin\<2.0mg/dl and AST, ALT, serum creatinine within twice of upper normal range, coagulation panel : within normal limit)
* Patients whose BMI(body mass index) is less than 35
* Patients who are supposed to have normal cognitive function
* Patients who signed the consent paper.
Exclusion Criteria:
* Patients who are expected to have malignant or metastatic adrenal tumor at preoperative exams
* Patients who have bilateral adrenal tumors
* Patients who have condition to undergo the other operation at the abdomen together with adrenalectomy
* Pregnant patients
* Patients who have active or uncontrolled infection
* Patients who have medical problems as below
* Uncontrollable hypertension with medication(Systolic BP\>150 or diastolic BP\>100)
* Angina, congestive heart failure, acute myocardial infection
* History of coronary angioplasty or Coronary artery bypass graft surgery
* History of stroke, transient ischemic attack with sequela
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Operation time
Timeframe: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks