Renal Failure ChronicLAPDOCTORNCT05769686
Laparoscopic Donor Nephrectomy Score, a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy
An observational study of Renal Failure Chronic and Surgery, run by Jacopo Romagnoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Failure Chronic, Surgery
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Candidates to living kidney donation
Who may be able to join
- Age of donor ≥ 18 yrs (minimum 18, maximum , deemed suitable for donation at the end of work-up
Who cannot join
- age< 18 yrs
- hypertension with organ damage
- unable to express proper consent to procedure
- evidence of coercion
- drug abuse
- evidence of malignancy
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Failure Chronic, Surgery
- Keywords
- living donation, laparoscopic nephrectomy, difficulty, scoring system
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
change in intraoperative complications
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start12 May 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacopo Romagnoli
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliera di Padova, Ospedale Pediatrico Bambin Gesù, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera Niguarda Cà Granda
- Responsible party
- Sponsor-investigator, Jacopo Romagnoli, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Jacopo Romagnoli, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769686
- Sponsor's protocol ID
- 2939
- Acronym
- LAPDOCTOR
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40336540
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAParoscopic DOnor nephreCTomy scORe (LAPDOCTOR) Multicenter Validation of a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT05769686
- Acronym / sponsor ID
- LAPDOCTOR / 2939
- Conditions
- Renal Failure Chronic, Surgery
- Keywords
- living donation, laparoscopic nephrectomy, difficulty, scoring system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jacopo RomagnoliUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliera di Padova, Ospedale Pediatrico Bambin Gesù, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera Niguarda Cà Granda
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates to living kidney donation
Key inclusion criteria (1 listed)
- Age of donor ≥ 18 yrs (minimum 18, maximum , deemed suitable for donation at the end of work-up
Key exclusion criteria (15 listed)
- age< 18 yrs
- hypertension with organ damage
- unable to express proper consent to procedure
- evidence of coercion
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
change in intraoperative complications
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 40336540Romagnoli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacopo Romagnoli, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure Chronic and Surgery, run by Jacopo Romagnoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of donors with a score between 26 and 33 in the LADOCTOR scale (risk of very difficult operation) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.