An observational study in Ureteropelvic Junction Obstruction, sponsored by National Children's Hospital, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by National Children's Hospital, Vietnam · Observational
Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature.
Open surgical dismembered pyeloplasty has historically been the gold standard for managing ureteropelvic junction obstruction (UPJO), boasting a success rate exceeding 94%. However, the requisite incision and muscle dissection can lead to increased postoperative pain, prolonged hospitalization, and undesirable scarring. In recent decades, there has been a growing interest in minimally invasive pyeloplasty, commencing with its inception in 1993. Laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP) have emerged as widely embraced and dependable therapeutic modalities for UPJO. Both techniques have demonstrated success rates comparable to those of open pyeloplasty while conferring advantages in terms of cosmetic outcomes and length of hospital stay.
However, despite their merits, minimally invasive approaches pose certain limitations in pediatric patients, including restricted working space, technical intricacies, prolonged operative time, steep learning curves, and the need for expensive instrumentation. Conventional laparoscopic pyeloplasty has encountered slow uptake due to its technical demands and substantial learning curve. The evolution of RALP over the past decade appears to mitigate the learning curve associated with intracorporeal suturing and anastomosis time. Nonetheless, RALP necessitates three to four port placements and a sizeable initial financial investment.
In 2007, Lima et al. introduced the retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) approach, which "combines the advantages of a minimally invasive technique with the high success rate of standard dismembered pyeloplasty". Several other researchers have replicated this technique with favorable outcomes. Nevertheless, a dearth of comprehensive studies delineating long-term follow-up and clinical outcomes persists in the medical literature. The aim of this study is to evaluate the long-term outcomes of OTAP.
26 studies on the registry are indexed under Multicystic renal dysplasia, bilateral; 9 are open to participants now.
Browse Multicystic renal dysplasia, bilateral studies →National Children's Hospital, Vietnam is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The cohort comprised seventy pediatric patients who underwent RALP for UPJO at the National Hospital of Pediatrics between May 2011 and June 2013. Preoperative diagnostic evaluations included blood tests, urinalysis, urine culture, renal ultrasonography (US), voiding cystourethrogram (VCUG) to exclude vesicoureteral reflux disease, magnetic resonance imaging (MRI) to exclude other associated renal pathologies, and technetium-99m diethylenetriamine penta-acetic acid (99mTc DTPA) scans.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
UPJO with severe hydronephrosis, with or without parenchymal atrophy (Society for Fetal Urology grade III or IV), recurrent urinary tract infections (UTI), prolonged drainage parameters with T1/2 \> 20 minutes, and/or differential renal function (DRF) less than 40%.
Procedure: One-trocar-assisted pyeloplasty
Positioned in a full lateral decubitus posture. A 12mm incision was made below the 12th rib, followed by a muscle-sparing technique to access and open the Gerota's fascia. A 10mm balloon trocar was inserted, and CO2 was insufflated to a pressure of 12 mmHg at a flow rate of 3L. An operative scope with dual channels was introduced for retroperitoneal dissection, utilizing a peanut to expand the working space. The proximal ureter, UPJ, and renal pelvis were visualized, and the UPJ was mobilized and exteriorized under direct visualization to prevent torsion. Anderson-Hynes dismembered pyeloplasty was performed using a 6/0 PDS suture, with possible enlargement of the incision if necessary. A 4 French double J ureteral stent was inserted antegradely before completing the anastomosis, verified by methylene blue presence at the anastomotic site. A final retroperitoneoscopic assessment ensured proper alignment of the anastomosis, with closure of the incision site without drain placement.
Operative time
The average and range of operative time (minutes) using the OTAP technique
Time frame: through study completion (3 years)
Conversion to open
Incidence in which the operation must be switch to open surgery
Time frame: through study completion (3 years)
Extension of skin incision
Incidence in which the original incision of the skin must be extended to accommodate UPJ mobilization
Time frame: through study completion (3 years)
Postoperative complications
Complications after OTAP including febrile UTI
Time frame: through study completion (3 years)
Median length of hospital stays
The average time (days) the patient stays at the hospital post-operation
Time frame: through study completion (3 years)
Median follow up length
The average time (months) the patient revisit the hospital for follow-up sessions
Time frame: through study completion (3 years)
Post-operative mean APD
The average anterior posterior diameter (mm) of the renal pelvis post-operation
Time frame: through study completion (3 years)
Post-operative mean DRF
The average different renal function (%) (measurement of each kidney's ability to extract tracer from blood) after the operation
Time frame: through study completion (3 years)
Mean incision length
The average length (mm) of the primary incision during the operation
Time frame: through study completion (3 years)
Recurrence
Instances of symptoms reappeared after the completion of the surgery
Time frame: through study completion (3 years)
Plan to share: No
Ran from May 2011 to primary completion in Jun 2013, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Multicystic renal dysplasia, bilateral →
National Children's Hospital, Vietnam