An observational study in Hydronephrosis, sponsored by Connecticut Children's Medical Center. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-20.
Sponsored by Connecticut Children's Medical Center · Observational
Performance and outcomes measure are, at this time, relatively unknown for robotic pyeloplasty procedures. The purpose of this study is to provide a clearer understanding of the urology department's robotic pyeloplasty quality and outcomes measures. This will be accomplished by prospectively collecting data for these procedures would ensure that measures are consistently collected in accordance with a defined protocol, allowing for more valuable quality and clinical research analysis.
Hypothesis will be defined before data analysis is performed. Amendments specifying future hypothesis will be submitted the IRB at the appropriate time.
Minimally invasive surgery is becoming a widely accepted method of surgery for many urological conditions. This includes both laparoscopy and robotic assisted laparoscopic surgery. In adult urology, there is discussion of laparoscopic pyeloplasty replacing open surgery as the gold standard in the treatment of ureteropelvic junction obstruction. Although at a slower rate, minimally invasive surgery is also becoming a standard method of treatment in the pediatric setting. Some urological surgeons are predicting that laparoscopy will become the standard of treatment in the straightforward pediatric nephrectomy. Benefits of laparoscopic surgery include improved cosmesis, reduced postoperative pain issues, and reduced length of stay. However, laparoscopic use for more delicate or complicated procedures has been limited due to 2-dimensional imaging, rigid non-articulating instruments, and the time and expense required for surgeons to master these techniques.
The advent of robotic surgery minimizes or eliminates many of these issues. Hand and wrist movements with the robot more closely mimic the actual hand and wrist movements in open surgery. Three-dimensional imaging provides the surgeon with necessary depth perception, articulating instruments with six degrees of freedom allow the surgeon to tie knots and suture more easily, and the learning curve has been reduced. Robotic surgery has the added benefit over laparoscopy with the introduction of tremor-filtering instruments and movement scaling. As of 2006, there were about 400 robots worldwide, and most were used primarily for urological surgery.
Currently, the most common procedure in pediatric robotic surgery is pyeloplasty, followed by fundoplication, and patent ductus arteriosus ligation. However, robotic surgery can be used in more difficult reconstructive surgeries, such as appendicovesicostomy and bladder augmentation in the pediatric population. The major impediment to widespread applications of minimally invasive surgery in pediatric procedures has been laparoscopic suturing. With increased accuracy, the advent of smaller instruments, and three-dimensional imaging, robotics is now a premier surgical advancement, and has allowed minimally invasive surgery to become a viable treatment method to a wider range of procedures and surgeons.
The first report of pediatric robotic surgery was published in 2002 and described successful surgeries of fundoplication, cholecystectomy, and salpingoophorectomy using the da Vinci robotic system. Two recent literature reviews of pediatric robotic surgery report that the majority of studies published in this area are either case report or case series.6 , One of the systematic reports was published in Spanish, so only the translated abstract was available to this department. The second systematic review reported that as of October 2007, there were 31 studies published describing 566 patients. Only four studies were case control, comparing robotic surgery with either laparoscopic or open procedures. Two of these case control reports described robotic assisted pyeloplasty in children compared to open surgery. As can be seen from these meta-analysis, published studies on robotic surgery is in its infancy and additional studies are necessary.
The purpose of this research is to provide a clearer understanding of the urology department's robotic pyeloplasty quality and outcomes measures. This will be accomplished by developing a database for research.
Specific Aim 1: To consistently collect performance and outcomes data for robotic pyeloplasty procedures in order to increase internal understanding of these procedures.
Specific Aim2: To consistently collect performance and outcomes data for robotic pyeloplasty procedures in order to perform more valuable clinical analysis for publication.
Hypothesis will be defined before data analysis is performed. Amendments specifying future hypothesis will be submitted the IRB at the appropriate time.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's enrollment of 78 is close to the median of 78 across 25 observational studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →Connecticut Children's Medical Center is the lead sponsor of 59 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children 0-18 years of age who receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children diagnosed with hydronephrosis who are to receive robotic pyeloplasty surgery
Resolution of Hydronephrosis
Time frame: 3 to 6 months after surgical intervention
Symptom Resolution at follow-up
Time frame: 3 to 6 months after surgical intervention
Drainage at Follow-up by MAG3
Time frame: 3 to 6 months after surgical intervention
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Connecticut Children's Medical Center