CompletedNot Applicable

Laparoscopic Donor Nephrectomy Score, a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy

Italy120 participantsStarted 2020-05-12

Plain-language summary

The goal of this multicenter observational study is to develope and validate a new scoring system for preoperative prediction of difficulty of Laparoscopic Donor Nephrectomy. Healthy living kidney donors will be enrolled. The main questions it aims to answer are: 1) can the investigators predict difficulty of the operation ? 2) Can the investigators score difficulty based on this new scoring system? Difficulty of LDN will be graded by the operating surgeon at the end of the operation based on intraoperative predefined parameters. All operations will be blindly scored by the operating surgeon, while one radiologist will blindly review all preoperative CT scans. LAPDOCTOR scores will be compared with the degrees of difficulty assigned by the operating surgeon to investigate the match rate.

Who can participate

Age range

18 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: \- Age of donor ≥ 18 yrs (minimum 18, maximum , deemed suitable for donation at the end of work-up Exclusion Criteria: * age\< 18 yrs * hypertension with organ damage * unable to express proper consent to procedure * evidence of coercion * drug abuse * evidence of malignancy * pregnancy * major respiratory or cardiovascular risk * diabetes mellitus * renal disease * systemic disease with renal involvement * thrombophilia * BMI \>35 * active infection * hepatitis B, hepatitis C and HIV

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

Number of donors with a score between 26 and 33 in the LADOCTOR scale (risk of very difficult operation)

Timeframe: 12 months

Trial details

NCT IDNCT05769686

SponsorJacopo Romagnoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Renal Failure Chronic trials