Clinical Trial: Prospective Pediatric Pyeloplasty Robotic Surgical Database
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Prospective Pediatric Pyeloplasty Robotic Surgical Database
Brief 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.
Detailed Summary:
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
Sponsor: Connecticut Children's Medical Center
Current Primary Outcome: Resolution of Hydronephrosis [ Time Frame: 3 to 6 months after surgical intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Connecticut Children's Medical Center
Dates:
Date Received: April 15, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 16, 2017
Last Verified: March 2017
