Clinical trial NCT05769686: Laparoscopic Donor Nephrectomy Score, a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy
Official title: LAParoscopic DOnor nephreCTomy scORe (LAPDOCTOR) Multicenter Validation of a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure Chronic
Surgery
Keywords: living donation
laparoscopic nephrectomy
difficulty
scoring system
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Azienda Ospedaliera di Padova
name: Ospedale Pediatrico Bambin Gesù
name: Azienda Ospedaliero-Universitaria di Parma
name: Azienda Ospedaliera Niguarda Cà Granda
First posted: 2023-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates to living kidney donation

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of donors with a score between 26 and 33 in the LADOCTOR scale (risk of very difficult operation)
timeFrame: 12 months
Secondary outcomes:
measure: change in intraoperative complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario A. Gemelli
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Jacopo Romagnoli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: