Robot-Assisted Pyeloplasty in Young Children

Completed

• Conditions: Ureterohydronephrosis; Ureter Obstruction; Child, Only

• Registration Number: NCT06734455
• Lead Sponsor: Destinval Christelle

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

Detailed Description

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

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-01
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
Presence of abdominal pain	Before surgery	Flank pain (pain in the upper abdomen or back)

Secondary Outcome Measures

Name	Time	Method
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
Postoperative pain	After surgery and before discharge home, up to 20 days	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."

Trial Locations

Locations (1)

University Hospital, Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France