CompletedNot Applicable

Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study

Egypt13 participantsStarted 2015-04

Plain-language summary

This randomized comparative study assesses the safety and efficacy of the posterior retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal approach and suppose that this new technique is a safe and effective alternative to the standard approach.

Who can participate

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 have one or more of the following; * Functioning adrenal adenoma, * Nonfunctioning adenoma \< 7 cm by pelvi-abdominal CT, * Secondary metastatic adrenal mass suitable for laparoscopic adrenalectomy, * Adrenal hyperplasia indicated for laparoscopic adrenalectomy. Exclusion Criteria: * Patients with cardiovascular disease (as angina, acute myocardial infection, congestive heart failure); history of stroke, transient myocardial attacks, coronary angioplasty or coronary artery bypass graft surgery, or any other contraindication for laparoscopy e.g. COPD, * Pregnant females, * Locally advanced malignant disease, * Evidence of regional lymph node involvement, * Vascular malignant invasion, * Malignant uncontrolled hypertension with pheochromocytoma, * Need for other simultaneous surgical intervention at the same session e.g. cholecystectomy.

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

Mean operative time

Timeframe: 1 year

Mean amount of intraoperative blood loss

Timeframe: 1 year

Mean days of postoperative hospital stay

Timeframe: 1 year

Rate of complications

Timeframe: 1.5 year

Trial details

NCT IDNCT02618694

SponsorSuez Canal University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Adrenal Mass trials

Who can participate

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.