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HydronephrosisNCT00882544

Prospective Pediatric Pyeloplasty Robotic Surgical Database

An observational study of Hydronephrosis, run by Connecticut Children's Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Hydronephrosis
How many people
78 participants
Where
1 siteUnited States
Study dates
Mar 2009to Oct 2016
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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • Subject did not receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
  • Subject does not sign informed consent and/or HIPAA Authorization

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

Other trials in United States

About this study

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.

Conditions
Hydronephrosis
Keywords
hydronephrosis, robotic pyeloplasty, pediatric pyeloplasty
Medical subject headings
Hydronephrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00882544
Study groupRoleWhat they receive
Diagnosed Pediatric HydronephrosisChildren diagnosed with hydronephrosis who are to receive robotic pyeloplasty surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of Hydronephrosis

    Measured: 3 to 6 months after surgical intervention

Secondary outcomes (2)
  1. Symptom Resolution at follow-up

    Measured: 3 to 6 months after surgical intervention

  2. Drainage at Follow-up by MAG3

    Measured: 3 to 6 months after surgical intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00882544
Sponsor's protocol ID
08-112
Status last verified
Mar 2017
First submitted
15 Apr 2009
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hydronephrosis, run by Connecticut Children's Medical Center at 1 site in United States.

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 2 inclusion and 2 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 20 Mar 2017. 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 United States. 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?

Resolution of Hydronephrosis (time frame: 3 to 6 months after surgical intervention). 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 NCT00882544, which also lists 9 linked publications.

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 20 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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