ClinicalTrials.gg
CompletedNCT00882544Updated Mar 20, 2017

Prospective Pediatric Pyeloplasty Robotic Surgical Database

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
Up to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hydronephrosis

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Keywords

  • hydronephrosis
  • robotic pyeloplasty
  • pediatric pyeloplasty
03

In context

Hydronephrosis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children 0-18 years of age who receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject received a robotic pyeloplasty procedure at Connecticut Children's Medical Center
  • Subject signs and HIPAA Authorization

Exclusion criteria

Exclusion Criteria:

  • Subject did not receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
  • Subject does not sign and/or HIPAA Authorization
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)

Groups and cohorts

  • Diagnosed Pediatric Hydronephrosis

    Children diagnosed with hydronephrosis who are to receive robotic pyeloplasty surgery

06

What researchers measure

Primary outcomes

  1. Resolution of Hydronephrosis

    Time frame: 3 to 6 months after surgical intervention

Secondary outcomes

  1. Symptom Resolution at follow-up

    Time frame: 3 to 6 months after surgical intervention

  2. Drainage at Follow-up by MAG3

    Time frame: 3 to 6 months after surgical intervention

07

Study locations

1 site
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
08

References and documents

Publications

  • Moon DA, El-Shazly MA, Chang CM, Gianduzzo TR, Eden CG. Laparoscopic pyeloplasty: evolution of a new gold standard. Urology. 2006 May;67(5):932-6. doi: 10.1016/j.urology.2005.11.024. Epub 2006 Apr 25. PubMed 16635516 ↗
  • Smaldone MC, Sweeney DD, Ost MC, Docimo SG. Laparoscopy in paediatric urology: present status. BJU Int. 2007 Jul;100(1):143-50. doi: 10.1111/j.1464-410X.2007.06854.x. Epub 2007 Apr 5. PubMed 17419701 ↗
  • Chacko JK, Koyle MA, Mingin GC, Furness PD 3rd. Minimally invasive open renal surgery. J Urol. 2007 Oct;178(4 Pt 2):1575-7; discussion 1577-8. doi: 10.1016/j.juro.2007.05.099. Epub 2007 Aug 16. PubMed 17707048 ↗
  • Meehan JJ, Meehan TD, Sandler A. Robotic fundoplication in children: resident teaching and a single institutional review of our first 50 patients. J Pediatr Surg. 2007 Dec;42(12):2022-5. doi: 10.1016/j.jpedsurg.2007.08.022. PubMed 18082700 ↗
  • Menon M, Hemal AK. Robotic urologic surgery: is this the way of the future? World J Urol. 2006 Jun;24(2):119. doi: 10.1007/s00345-006-0081-3. No abstract available. PubMed 16622692 ↗
  • Passerotti C, Peters CA. Robotic-assisted laparoscopy applied to reconstructive surgeries in children. World J Urol. 2006 Jun;24(2):193-7. doi: 10.1007/s00345-006-0084-0. No abstract available. PubMed 16758249 ↗
  • Lee RS, Borer JG. Robotic surgery for ureteropelvic junction obstruction. Curr Opin Urol. 2006 Jul;16(4):291-4. doi: 10.1097/01.mou.0000232052.74342.a0. PubMed 16770130 ↗
  • Gutt CN, Markus B, Kim ZG, Meininger D, Brinkmann L, Heller K. Early experiences of robotic surgery in children. Surg Endosc. 2002 Jul;16(7):1083-6. doi: 10.1007/s00464-001-9151-1. Epub 2002 Apr 9. PubMed 12165827 ↗
  • Estrada CR, Passerotti CC. [Robotic surgery in pediatric urology]. Arch Esp Urol. 2007 May;60(4):471-9. doi: 10.4321/s0004-06142007000400017. Spanish. PubMed 17626539 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00882544
Lead sponsor
Connecticut Children's Medical Center
Responsible party
Sponsor
First posted
Apr 16, 2009
Start date
Mar 2009
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Mar 20, 2017

Study contacts

Katherine W Herbst, M.Sc
study director · Connecticut Children's Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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