Robot-Assisted Pyeloplasty in Young Children (PYEROB)

May 14, 2023 updated by: Dr Christelle DESTINVAL, University of Lorraine

Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old: a Monocentric Retrospective Study

The goal of this retrospective study is to analyse the outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old:

  • indication criteria
  • clinical symptoms
  • operating time
  • length of stay
  • complications
  • follow-up

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old and comparison with the outcomes in the literature.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Grand-Est
      • Vandœuvre-lès-Nancy, Grand-Est, France, 54500
        • ULorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients younger than 5 years old, with pyeloureteric syndrome, who underwent primary robotic pyeloplasty

Description

Inclusion Criteria:

  • Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

Exclusion Criteria:

  • Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of abdominal pain
Time Frame: Before surgery
Flank pain (pain in the upper abdomen or back)
Before surgery
Presence of urinary calculi
Time Frame: Before surgery
Urinary calculi can be diagnosed on an abdominal X-Ray, an abdominal Ultrasound or an abdominal CT scan
Before surgery
Presence of abnormal nuclear renal scans
Time Frame: Before surgery
Nuclear renal scans are abnormal when there is a difference of filtration of more than 40% between the kidneys
Before surgery
Presence of urinary tract infection
Time Frame: Before surgery
Urinary tract infection associated with ureteropelvic junction
Before surgery
Presence of ureterohydronephrosis
Time Frame: Before surgery
Ureterohydronephrosis represents the augmentation of the diameter of the ureter (more than 10 millimeters) and the renal pelvis (more than 30 millimeters), which can be measured on imaging such as abdominal ultrasound, CT scan, or MRI. Whenever the ureter and the renal pelvis meet these criteria on preoperative imaging, the patient will be labeled as having ureterohydronephrosis.
Before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: After surgery and before discharge home, up to 20 days
Mean Digital Pain scale
After surgery and before discharge home, up to 20 days
Postoperative complications
Time Frame: Through study completion, an average of 2 years
Pyelonephritis
Through study completion, an average of 2 years
Operation time
Time Frame: During surgery
anesthetic and operating time
During surgery
hospitalization length
Time Frame: From admission to discharge home, up to 20 days
hospitalization length
From admission to discharge home, up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lorraine

Investigators

  • Principal Investigator: Christelle Destinval, MD, University of Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULoripyel
  • 2023PI007 (Registry Identifier: DRCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the name of anonymization the investigators won't share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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