Prospective Pediatric Pyeloplasty Robotic Surgical Database
NCT ID: NCT00882544
Last Updated: 2017-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
78 participants
OBSERVATIONAL
2009-03-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis will be defined before data analysis is performed. Amendments specifying future hypothesis will be submitted the IRB at the appropriate time.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Pediatric Vesicoureteral Reflux Surgery Database
NCT01373385
Robot-Assisted Pyeloplasty in Young Children
NCT06734455
Pediatric Robotic Versus Open Pyeloplasty
NCT04884945
Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic
NCT01349244
Prospective Cohort of Transitional Urology Patients
NCT03061084
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diagnosed Pediatric Hydronephrosis
Children diagnosed with hydronephrosis who are to receive robotic pyeloplasty surgery
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject signs informed consent and HIPAA Authorization
Exclusion Criteria
* Subject does not sign informed consent and/or HIPAA Authorization
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Connecticut Children's Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katherine W Herbst, M.Sc
Role: STUDY_DIRECTOR
Connecticut Children's Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Estrada CR, Passerotti CC. [Robotic surgery in pediatric urology]. Arch Esp Urol. 2007 May;60(4):471-9. doi: 10.4321/s0004-06142007000400017. Spanish.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-112
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.