Robot-Assisted Pyeloplasty in Young Children

NCT06734455 | Completed

• 1 other identifier: M24DC1107
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Ureterohydronephrosis; Ureter Obstruction; Child, Only

Keywords

Robot-Assisted Pyeloplasty; Child; Retrospective Study

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (4)

• Postoperative pain

  After surgery and before discharge home, up to 20 days

• Postoperative complications

  Through study completion, an average of 2 years

• Operation time

  During surgery

• Hospitalization length

  From admission to discharge home, up to 20 days

Interventions

Robot-Assisted Pyeloplasty OTHER

Pyeloplasty in Children using robotic surgery

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients younger than 5 years old, with pyeloureteric syndrome, who underwent primary robotic pyeloplasty

You may qualify if:

• Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

You may not qualify if:

• Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

Sponsors & Collaborators

• Destinval Christelle: lead

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 36913057 BACKGROUND

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: November 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: December 18, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)