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

NCT05769686 | Completed DMC

• 1 other identifier: 2939
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Failure Chronic; Surgery

Keywords

living donation; laparoscopic nephrectomy; difficulty; scoring system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in intraoperative complications

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Candidates to living kidney donation

You may qualify if:

• \- Age of donor ≥ 18 yrs (minimum 18, maximum , deemed suitable for donation at the end of work-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacopo Romagnoli: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Azienda Ospedaliera di Padova: collaborator
• Ospedale Pediatrico Bambin Gesù: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator

Study Sites (1)

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

Location

Related Publications (1)

• Romagnoli J, Spagnoletti G, Rossini FE, Iezzi R, Posa A, Salerno MP, Silvestri P, Rossini AE, Silvestre C, Franchin B, Giacomoni A, Centonze L, Spada M, Iaria M, Puliatti C, Furian L. Lapdoctor: Multicentre Validation of a Scoring System for Preoperative Evaluation of Difficulty of Laparoscopic Donor Nephrectomy. Transpl Int. 2025 Apr 23;38:14100. doi: 10.3389/ti.2025.14100. eCollection 2025.

  PMID: 40336540 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacopo Romagnoli, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgical Director Renal Transplant Unit, MD, PhD

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 15, 2023
• Study Start: May 12, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

IT (1)