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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Renal Failure Chronic

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Candidates to living kidney donation

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of donors with a score between 26 and 33 in the LADOCTOR scale (risk of very difficult operation)	The LAPDCOTOR scoring programme calculates the score based on presence, absence of certain characteristics (Sex, BMI, different radiologic measurements, etc.). A score of 1 or 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).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
change in intraoperative complications	24 months

Collaborators and Investigators

• Sponsor: Jacopo Romagnoli
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera di Padova; Azienda Ospedaliero-Universitaria di Parma; Azienda Ospedaliera Niguarda Cà Granda; Ospedale Pediatrico Bambin Gesù
• Investigators: Principal Investigator: Jacopo Romagnoli, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: scoring system; living donation; laparoscopic nephrectomy; difficulty
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 2939

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No