PYEROB: Robot-Assisted Pyeloplasty in Young Children

Sponsor

University of Lorraine (Other)

Overall Status

Completed

CT.gov ID

NCT05858658

Collaborator

(none)

Enrollment

Location

5.3

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Ureterohydronephrosis Ureter Obstruction Child, Only	Other: Robot-Assisted Pyeloplasty

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Apr 10, 2023

Outcome Measures

Primary Outcome Measures

Presence of ureterohydronephrosis [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.
Presence of abdominal pain [Before surgery]
Flank pain (pain in the upper abdomen or back)
Presence of urinary calculi [Before surgery]
Urinary calculi can be diagnosed on an abdominal X-Ray, an abdominal Ultrasound or an abdominal CT scan
Presence of abnormal nuclear renal scans [Before surgery]
Nuclear renal scans are abnormal when there is a difference of filtration of more than 40% between the kidneys
Presence of urinary tract infection [Before surgery]
Urinary tract infection associated with ureteropelvic junction

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 5 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ULorraine	Vandœuvre-lès-Nancy	Grand-Est	France	54500

Sponsors and Collaborators

University of Lorraine

Investigators

Principal Investigator: Christelle Destinval, MD, University of Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine

ClinicalTrials.gov Identifier:

NCT05858658

Other Study ID Numbers:

ULoripyel
2023PI007

First Posted:

May 15, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine

Robot-Assisted Pyeloplasty

Children

Retrospective Study

Study Results

No Results Posted as of May 16, 2023