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OpenTrials
Completed

NCT Number: NCT05769686

Laparoscopic Donor Nephrectomy Score, 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of donors with a score between 26 and 33 in the LADOCTOR scale (risk of very difficult operation)

    Time frame: 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 outcomes

  1. change in intraoperative complications

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Jacopo Romagnoli

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LAPDOCTOR

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 15, 2023
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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