Child, Only Clinical Trial
— PYEROBOfficial title:
Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old: a Monocentric Retrospective Study
Verified date | May 2023 |
Source | University of Lorraine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 9 |
Est. completion date | April 10, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
France | ULorraine | Vandœuvre-lès-Nancy | Grand-Est |
Lead Sponsor | Collaborator |
---|---|
University of Lorraine |
France,
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
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 |
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