CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
One-trocar-assisted pyeloplastyprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06349161
NCT06349161N/ACompleted

Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience

National Children's Hospital, Vietnam·observational·Posted Apr 5, 2024·Updated Apr 5, 2024

In Brief

An observational study evaluating One-trocar-assisted pyeloplasty for Ureteropelvic Junction Obstruction. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesVietnam
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 5, 2024
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2013
Study CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 2.2 years ago

Interventions

One-trocar-assisted pyeloplastyprocedure

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.