UreterohydronephrosisPYEROBNCT06734455
Robot-Assisted Pyeloplasty in Young Children
An observational study of Ureterohydronephrosis and Ureter Obstruction, run by Destinval Christelle at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Ureterohydronephrosis, Ureter Obstruction, Child, Only
- What is being tested?
- Robot-Assisted Pyeloplasty
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients younger than 5 years old, with pyeloureteric syndrome, who underwent primary robotic pyeloplasty
Who may be able to join
- Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022
Who cannot join
- Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
About this study
Official title: 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
Read the detailed description
Outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old and comparison with the outcomes in the literature.
- Conditions
- Ureterohydronephrosis, Ureter Obstruction, Child, Only
- Being tested
- Robot-Assisted Pyeloplasty
- Keywords
- Robot-Assisted Pyeloplasty, Child, Retrospective Study
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted PyeloplastyOther
Pyeloplasty in Children using robotic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery
Presence of abdominal pain
Flank pain (pain in the upper abdomen or back)
Measured: Before surgery
Presence of urinary calculi
Urinary calculi can be diagnosed on an abdominal X-Ray, an abdominal Ultrasound or an abdominal CT scan
Measured: 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
Measured: Before surgery
Presence of urinary tract infection
Urinary tract infection associated with ureteropelvic junction
Measured: Before surgery
Secondary outcomes (4)
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."
Measured: After surgery and before discharge home, up to 20 days
Postoperative complications
Pyelonephritis
Measured: Through study completion, an average of 2 years
Operation time
anesthetic and operating time
Measured: During surgery
Hospitalization length
Hospitalization length
Measured: From admission to discharge home, up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Nov 2022
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UreterohydronephrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Destinval Christelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734455
- Sponsor's protocol ID
- M24DC1107
- Acronym
- PYEROB
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the name of anonymization the investigators won't share individual participant data
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.
PubMed 36913057
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old
- ClinicalTrials.gov ID
- NCT06734455
- Acronym / sponsor ID
- PYEROB / M24DC1107
- Conditions
- Ureterohydronephrosis, Ureter Obstruction, Child, Only
- Keywords
- Robot-Assisted Pyeloplasty, Child, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Destinval ChristelleUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients younger than 5 years old, with pyeloureteric syndrome, who underwent primary robotic pyeloplasty
Key inclusion criteria (1 listed)
- Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022
Key exclusion criteria (1 listed)
- Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted PyeloplastyPyeloplasty in Children using robotic surgery | Other | – |
Primary outcome
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.
Presence of abdominal pain
Time frame: Before surgery
Flank pain (pain in the upper abdomen or back)
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
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
Presence of urinary tract infection
Time frame: Before surgery
Urinary tract infection associated with ureteropelvic junction
4 secondary outcomes
Postoperative pain
Time frame: After surgery and before discharge home, up to 20 days
Postoperative complications
Time frame: Through study completion, an average of 2 years
Operation time
Time frame: During surgery
Hospitalization length
Time frame: From admission to discharge home, up to 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 36913057Esposito 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.
- Individual participant dataSharing planned: No. In the name of anonymization the investigators won't share individual participant data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureterohydronephrosis and Ureter Obstruction, run by Destinval Christelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of ureterohydronephrosis (time frame: Before surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.