Robot-Assisted Pyeloplasty in Young Children (PYEROB)

Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old

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: Child, Only; Ureter Obstruction; Ureterohydronephrosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • University Hospital, Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of abdominal pain	Flank pain (pain in the upper abdomen or back)	Before surgery
Presence of urinary calculi	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	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	Urinary tract infection associated with ureteropelvic junction	Before surgery
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Pyelonephritis	Through study completion, an average of 2 years
Operation time	anesthetic and operating time	During surgery
Hospitalization length	Hospitalization length	From admission to discharge home, up to 20 days
Postoperative pain	The numeric rating scale (NRS) is a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and ten meaning "the worst pain imaginable."	After surgery and before discharge home, up to 20 days

Collaborators and Investigators

• Sponsor: Destinval Christelle

Publications and helpful links

General Publications

• 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 Aug;17(4):1239-1246. doi: 10.1007/s11701-023-01559-1. Epub 2023 Mar 13.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Child; Retrospective Study; Robot-Assisted Pyeloplasty
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Ureteral Diseases; Ureteral Obstruction
• Other Study ID Numbers: M24DC1107

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
• product manufactured in and exported from the U.S.: No