Robot-Assisted Pyeloplasty in Young Children

Child, Only Clinical Trial

— PYEROB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858658
• Other study ID #: ULoripyel
• Secondary ID: 2023PI007
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Child, Only
• Ureter Obstruction
• Ureteral Obstruction

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