Clinical Trials Directory

Trials / Completed

CompletedNCT05769686

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

LAParoscopic DOnor nephreCTomy scORe (LAPDOCTOR) Multicenter Validation of a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy

Status
Completed
Phase
Study type
Observational
Enrollment
120 (actual)
Sponsor
Jacopo Romagnoli · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed description

The LAPDOCTOR scoring programme calculates the score based on presence, absence of certain characteristics (Sex, BMI, different radiologic measurements, etc.). A score of 1 to 2 is assigned to each characteristics . Difficulty is graded as standard when the sum is between 11 and 18, moderately difficult between 19 and 25, very difficult between 26 and 33). At the end of the operation the donor surgeon will score the difficulty assigning a score of 1 to 3 to each phase of the operation, the resulting score will define again three degree of difficulty (standard 1-8, moderately difficult 9-16, very difficult 17-24.

Conditions

Timeline

Start date
2020-05-12
Primary completion
2021-06-30
Completion
2022-12-31
First posted
2023-03-15
Last updated
2023-03-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05769686. Inclusion in this directory is not an endorsement.