Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience
- Conditions
- Ureteropelvic Junction Obstruction
- Interventions
- Procedure: One-trocar-assisted pyeloplasty
- Registration Number
- NCT06349161
- Lead Sponsor
- National Children's Hospital, Vietnam
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Children 6 months to 5 years old with UPJ obstruction who underwent OTAP between May 2011 and June 2013.
- Anteroposterior renal pelvic diameter of 20 mm or greater, which demonstrated progressive enlargement on subsequent ultrasounds, coupled with impaired split renal function of 40% or less on nuclear scan, characterized by a T1/2 > 20 minutes
- The surgical technique performed must be one trocar-assisted pyeloplasty
- A history of previous renal surgery
- UPJO associated with other urinary tract anomalies
- Identification of crossing lower pole renal vessels as the cause of obstruction.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ureteropelvic junction obstruction One-trocar-assisted pyeloplasty 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%.
- Primary Outcome Measures
Name Time Method Conversion to open through study completion (3 years) Incidence in which the operation must be switch to open surgery
Post-operative mean DRF through study completion (3 years) The average different renal function (%) (measurement of each kidney's ability to extract tracer from blood) after the operation
Postoperative complications through study completion (3 years) Complications after OTAP including febrile UTI
Operative time through study completion (3 years) The average and range of operative time (minutes) using the OTAP technique
Extension of skin incision through study completion (3 years) Incidence in which the original incision of the skin must be extended to accommodate UPJ mobilization
Median follow up length through study completion (3 years) The average time (months) the patient revisit the hospital for follow-up sessions
Median length of hospital stays through study completion (3 years) The average time (days) the patient stays at the hospital post-operation
Post-operative mean APD through study completion (3 years) The average anterior posterior diameter (mm) of the renal pelvis post-operation
Recurrence through study completion (3 years) Instances of symptoms reappeared after the completion of the surgery
Mean incision length through study completion (3 years) The average length (mm) of the primary incision during the operation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The National Hospital of Pediatrics
🇻🇳Hanoi, Vietnam