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.
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
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 group | Role | What they receive |
|---|---|---|
| Diagnosed Pediatric Hydronephrosis | Children 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.
Resolution of Hydronephrosis
Measured: 3 to 6 months after surgical intervention
Secondary outcomes (2)
Symptom Resolution at follow-up
Measured: 3 to 6 months after surgical intervention
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.
- First posted16 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HydronephrosisStudies 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
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine W Herbst, M.Sc, Study director, Connecticut Children's Medical Center
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 16635516Smaldone 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 17419701Chacko 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 17707048Meehan 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 18082700Menon 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 16622692Passerotti 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 16758249Lee 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 16770130Gutt 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 12165827Estrada 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pediatric Pyeloplasty Robotic Surgical Database
- ClinicalTrials.gov ID
- NCT00882544
- Acronym / sponsor ID
- 08-112
- Conditions
- Hydronephrosis
- Keywords
- hydronephrosis, robotic pyeloplasty, pediatric pyeloplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Apr 2009 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed Pediatric Hydronephrosis | – | –Children diagnosed with hydronephrosis who are to receive robotic pyeloplasty surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children 0-18 years of age who receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
Key inclusion criteria (2 listed)
- Subject received a robotic pyeloplasty procedure at Connecticut Children's Medical Center
- Subject signs informed consent and HIPAA Authorization
Key exclusion criteria (2 listed)
- Subject did not receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
- Subject does not sign informed consent and/or HIPAA Authorization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resolution of Hydronephrosis
Time frame: 3 to 6 months after surgical intervention
2 secondary outcomes
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
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 20 Mar 2017.
- Background: PubMed 16635516Moon 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.
- Background: PubMed 17419701Smaldone 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.
- Background: PubMed 17707048Chacko 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.
- Background: PubMed 18082700Meehan 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.
- Background: PubMed 16622692Menon 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.
- Background: PubMed 16758249Passerotti 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.
- Background: PubMed 16770130Lee 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.
- Background: PubMed 12165827Gutt 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.
- Background: PubMed 17626539Estrada CR, Passerotti CC. [Robotic surgery in pediatric urology]. Arch Esp Urol. 2007 May;60(4):471-9. doi: 10.4321/s0004-06142007000400017. Spanish.
- Individual participant dataSharing planned: No
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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.
Katherine W Herbst, M.Sc study director
Connecticut Children's Medical Center
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 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.