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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05769686

Acronym

LAPDOCTOR

Enrollment

120

Registered

2023-03-15

Start date

2020-05-12

Completion date

2022-12-31

Last updated

2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure Chronic, Surgery

Keywords

living donation, laparoscopic nephrectomy, difficulty, scoring system

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of donors with a score between 26 and 33 in the LADOCTOR scale (risk of very difficult operation)	12 months	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).

Secondary

Measure	Time frame
change in intraoperative complications	24 months

Countries

Italy

Outcome results