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Completed

NCT Number: NCT06734455

Robot-Assisted Pyeloplasty in Young Children

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

Completed

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Key information

Conditions

Ureterohydronephrosis Child, Only Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Ureter Obstruction Ureteral Diseases Ureteral Obstruction Urogenital Diseases Urologic Diseases

Age range

0 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-Assisted Pyeloplasty

Other

Pyeloplasty in Children using robotic surgery

Primary outcomes

  1. Presence of ureterohydronephrosis

    Time frame: 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.

  2. Presence of abdominal pain

    Time frame: Before surgery

    Flank pain (pain in the upper abdomen or back)

  3. Presence of urinary calculi

    Time frame: Before surgery

    Urinary calculi can be diagnosed on an abdominal X-Ray, an abdominal Ultrasound or an abdominal CT scan

  4. Presence of abnormal nuclear renal scans

    Time frame: Before surgery

    Nuclear renal scans are abnormal when there is a difference of filtration of more than 40% between the kidneys

  5. Presence of urinary tract infection

    Time frame: Before surgery

    Urinary tract infection associated with ureteropelvic junction

Secondary outcomes

  1. Postoperative pain

    Time frame: 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."

  2. Postoperative complications

    Time frame: Through study completion, an average of 2 years

    Pyelonephritis

  3. Operation time

    Time frame: During surgery

    anesthetic and operating time

  4. Hospitalization length

    Time frame: From admission to discharge home, up to 20 days

    Hospitalization length

Sponsors and collaborators

Lead sponsor

Destinval Christelle

Other

Registry information

Official study title

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

Acronym: PYEROB

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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