Clinical Trial: Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Prospective Randomized Trial of Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty
Brief Summary: This prospective study, Randomized Trial of Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty will consist of four steps: 1.) Enrolling subjects in the study and signing the consent form 2.) Randomly divide subjects into 2 groups, group 1 will have internal stent and group 2 will have external stent 3.) At the time of stent removal in the clinic or in the OR subjects parents/ subjects will fill a questionnaire about pain after the procedure, stent care and stent tolerance and 4) Data from the questionnaires and procedure cost will be collected and all the data will be analyzed
Detailed Summary:
The pyeloplasty is a surgical procedure to treat kidney obstruction due to congenital or acquired causes. Congenital like congenital stenosis in the Uretero-pelvic junction (UPJ) or due to crossing blood vessels. Acquired causes like UPJ obstruction post stone disease or renal trauma. For the congenital or the acquired causes the principle of the surgery is to remove the UPJ stenosis (the diseased segment of the ureter) and reconnect the ureter to the renal pelvis again. This procedure is known as dismembered pyeloplasty. It was described in 1940 by Anderson and since then still the gold standard procedure regardless of the approach (open, laparoscopic or robotic). One of the principles of the procedure is to 'Splint' the anastomosis, i.e put something across the anastomosis during the healing process that includes internal and external stents. Also there are surgeons even don't believe in keeping anything across the anastomosis, but they leave a nephrostomy tube only that will not cross the anastomosis. In our division at CHP, we believe that we should keep a stent across the anastomosis to help in the healing process and decrease that chance of intra-abdominal urine leak and to increase the chance of success (90-99%). So for the internal stent, we use to approaches to insert it: 1- Retrograde by cystoscopy and this will take 10 minutes before starting the surgical procedure itself and we put the stent under fluoroscopy guidance and this is the commonest way we use now to put the internal stents. 2- ante grade, and this is basically inserting the stent during the surgical procedure itself from the kidney down to the ureter and this is done without fluoroscopy. For the external stent we use one method, we choose were we will leave the stent and then we create a small hole in the kidney and then pull the stent through the hole and then create small hole in the abdominal fascia and then the skin, all this done under direct
Sponsor: Children's Hospital of Pittsburgh
Current Primary Outcome:
- Comparison of the two different Stents [ Time Frame: 4-6 weeks until the stent is removed ]Post-operative pain control and tolerance
- Comparison of the two different Stents removal [ Time Frame: 4-6 weeks until the stent is removed ]the ease of stent removal
- Comparison of the two different Stents patient satisfaction [ Time Frame: 4-6 weeks until the stent is removed ]Patient/parents satisfaction and cost
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Compare patient/parent reported tolerance [ Time Frame: 4-6 weeks until the stent is removed ]assess the patient/parent reported outcomes for post-operative pain, tolerance
- Compare patient/parent reported outcome [ Time Frame: 4-6 weeks until the stent is removed ]ease of stent removal will be measured
Original Secondary Outcome: Same as current
Information By: Children's Hospital of Pittsburgh
Dates:
Date Received: February 23, 2016
Date Started: January 2016
Date Completion: June 2018
Last Updated: September 13, 2016
Last Verified: September 2016
