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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05858658
Other study ID # ULoripyel
Secondary ID 2023PI007
Status Completed
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date April 10, 2023

Study information

Verified date May 2023
Source University of Lorraine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date April 10, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group N/A to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Robot-Assisted Pyeloplasty
Pyeloplasty in Children using robotic surgery

Locations

Country Name City State
France ULorraine Vandœuvre-lès-Nancy Grand-Est

Sponsors (1)

Lead Sponsor Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & Publications (2)

Esposito C, Cerulo M, Lepore B, Coppola V, D'Auria D, Esposito G, Carulli R, Del Conte F, Escolino M. Robotic-assisted pyeloplasty in children: a systematic review of the literature. J Robot Surg. 2023 Mar 13. doi: 10.1007/s11701-023-01559-1. Online ahead of print. — View Citation

Trachta J, Kucerova B, Rygl M. Robotic pyeloplasty in children - a pilot study. Rozhl Chir. 2022 Winter;101(2):79-84. doi: 10.33699/PIS.2022.101.2.79-84. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of ureterohydronephrosis 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
Primary Presence of abdominal pain Flank pain (pain in the upper abdomen or back) Before surgery
Primary Presence of urinary calculi Urinary calculi can be diagnosed on an abdominal X-Ray, an abdominal Ultrasound or an abdominal CT scan Before surgery
Primary Presence of abnormal nuclear renal scans Nuclear renal scans are abnormal when there is a difference of filtration of more than 40% between the kidneys Before surgery
Primary Presence of urinary tract infection Urinary tract infection associated with ureteropelvic junction Before surgery
Secondary Postoperative pain Mean Digital Pain scale After surgery and before discharge home, up to 20 days
Secondary Postoperative complications Pyelonephritis Through study completion, an average of 2 years
Secondary Operation time anesthetic and operating time During surgery
Secondary hospitalization length hospitalization length From admission to discharge home, up to 20 days
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