Viewing Study NCT06349161



Ignite Creation Date: 2024-05-06 @ 8:20 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06349161
Status: COMPLETED
Last Update Posted: 2024-04-05
First Post: 2024-03-31

Brief Title: Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty A Single-center and Single-surgeon Experience
Sponsor: National Childrens Hospital Vietnam
Organization: National Childrens Hospital Vietnam

Study Overview

Official Title: Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty A Single-center and Single-surgeon Experience
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None