Ureteropelvic Junction ObstructionNCT06349161
Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience
An observational study of Ureteropelvic Junction Obstruction, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Ureteropelvic Junction Obstruction
- What is being tested?
- One-trocar-assisted pyeloplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteVietnam
- Study dates
- May 2011to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ureteropelvic Junction Obstruction
- Being tested
- One-trocar-assisted pyeloplasty
- Keywords
- Hydronephrosis, Laparoscopic, Pyeloplasty, Minimally invasive, Ureteropelvic junction obstruction
- Medical subject headings
- Multicystic renal dysplasia, bilateral, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-trocar-assisted pyeloplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ureteropelvic junction obstruction | 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%. Receives: Procedure: One-trocar-assisted pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The average and range of operative time (minutes) using the OTAP technique
Measured: through study completion (3 years)
Conversion to open
Incidence in which the operation must be switch to open surgery
Measured: 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
Measured: through study completion (3 years)
Postoperative complications
Complications after OTAP including febrile UTI
Measured: through study completion (3 years)
Median length of hospital stays
The average time (days) the patient stays at the hospital post-operation
Measured: through study completion (3 years)
Median follow up length
The average time (months) the patient revisit the hospital for follow-up sessions
Measured: through study completion (3 years)
Post-operative mean APD
The average anterior posterior diameter (mm) of the renal pelvis post-operation
Measured: 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
Measured: through study completion (3 years)
Mean incision length
The average length (mm) of the primary incision during the operation
Measured: through study completion (3 years)
Recurrence
Instances of symptoms reappeared after the completion of the surgery
Measured: through study completion (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study startMay 2011
- Primary completionJun 2013
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thanh Quang, National Children's Hospital, Vietnam
- Investigators
- Quang T Nguyen, M.D., Principal investigator, : Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349161
- Sponsor's protocol ID
- 1451_02/BVNTW-VNCSKTE
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ANDERSON JC, HYNES W. Retrocaval ureter; a case diagnosed pre-operatively and treated successfully by a plastic operation. Br J Urol. 1949 Sep;21(3):209-14. doi: 10.1111/j.1464-410x.1949.tb10773.x. No abstract available.
PubMed 18148283Mikkelsen SS, Rasmussen BS, Jensen TM, Hanghoj-Petersen W, Christensen PO. Long-term follow-up of patients with hydronephrosis treated by Anderson-Hynes pyeloplasty. Br J Urol. 1992 Aug;70(2):121-4. doi: 10.1111/j.1464-410x.1992.tb15688.x.
PubMed 1393432Schuessler WW, Grune MT, Tecuanhuey LV, Preminger GM. Laparoscopic dismembered pyeloplasty. J Urol. 1993 Dec;150(6):1795-9. doi: 10.1016/s0022-5347(17)35898-6.
PubMed 8230507Inagaki T, Rha KH, Ong AM, Kavoussi LR, Jarrett TW. Laparoscopic pyeloplasty: current status. BJU Int. 2005 Mar;95 Suppl 2:102-5. doi: 10.1111/j.1464-410X.2005.05208.x.
PubMed 15720343Braga LH, Lorenzo AJ, Bagli DJ, Mahdi M, Salle JL, Khoury AE, Farhat WA. Comparison of flank, dorsal lumbotomy and laparoscopic approaches for dismembered pyeloplasty in children older than 3 years with ureteropelvic junction obstruction. J Urol. 2010 Jan;183(1):306-11. doi: 10.1016/j.juro.2009.09.008.
PubMed 19914659Sweeney DD, Ost MC, Schneck FX, Docimo SG. Laparoscopic pyeloplasty for ureteropelvic junction obstruction in children. J Laparoendosc Adv Surg Tech A. 2011 Apr;21(3):261-5. doi: 10.1089/lap.2010.0155. Epub 2011 Feb 1.
PubMed 21284513Piaggio LA, Franc-Guimond J, Noh PH, Wehry M, Figueroa TE, Barthold J, Gonzalez R. Transperitoneal laparoscopic pyeloplasty for primary repair of ureteropelvic junction obstruction in infants and children: comparison with open surgery. J Urol. 2007 Oct;178(4 Pt 2):1579-83. doi: 10.1016/j.juro.2007.03.159. Epub 2007 Aug 16.
PubMed 17707047Hemal AK, Goel R, Goel A. Cost-effective laparoscopic pyeloplasty: single center experience. Int J Urol. 2003 Nov;10(11):563-8. doi: 10.1046/j.1442-2042.2003.00706.x.
PubMed 14633078Boysen WR, Gundeti MS. Robot-assisted laparoscopic pyeloplasty in the pediatric population: a review of technique, outcomes, complications, and special considerations in infants. Pediatr Surg Int. 2017 Sep;33(9):925-935. doi: 10.1007/s00383-017-4082-7. Epub 2017 Apr 1.
PubMed 28365863Passerotti CC, Passerotti AM, Dall'Oglio MF, Leite KR, Nunes RL, Srougi M, Retik AB, Nguyen HT. Comparing the quality of the suture anastomosis and the learning curves associated with performing open, freehand, and robotic-assisted laparoscopic pyeloplasty in a swine animal model. J Am Coll Surg. 2009 Apr;208(4):576-86. doi: 10.1016/j.jamcollsurg.2009.01.010.
PubMed 19476793Howe A, Kozel Z, Palmer L. Robotic surgery in pediatric urology. Asian J Urol. 2017 Jan;4(1):55-67. doi: 10.1016/j.ajur.2016.06.002. Epub 2016 Sep 6.
PubMed 29264208Song SH, Lee C, Jung J, Kim SJ, Park S, Park H, Kim KS. A comparative study of pediatric open pyeloplasty, laparoscopy-assisted extracorporeal pyeloplasty, and robot-assisted laparoscopic pyeloplasty. PLoS One. 2017 Apr 20;12(4):e0175026. doi: 10.1371/journal.pone.0175026. eCollection 2017.
PubMed 28426695Monn MF, Bahler CD, Schneider EB, Whittam BM, Misseri R, Rink RC, Sundaram CP. Trends in robot-assisted laparoscopic pyeloplasty in pediatric patients. Urology. 2013 Jun;81(6):1336-41. doi: 10.1016/j.urology.2013.01.025. Epub 2013 Mar 19.
PubMed 23522294Lima M, Tursini S, Ruggeri G, Gargano T, Libri M, Domini M. One trocar assisted pyeloplasty (OTAP): initial experience and codification of a technique. Pediatr Med Chir. 2007 Mar-Apr;29(2):108-11.
PubMed 17461099Mei H, Pu J, Yang C, Zhang H, Zheng L, Tong Q. Laparoscopic versus open pyeloplasty for ureteropelvic junction obstruction in children: a systematic review and meta-analysis. J Endourol. 2011 May;25(5):727-36. doi: 10.1089/end.2010.0544. Epub 2011 Apr 8.
PubMed 21476861
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience
- ClinicalTrials.gov ID
- NCT06349161
- Acronym / sponsor ID
- 1451_02/BVNTW-VNCSKTE
- Conditions
- Ureteropelvic Junction Obstruction
- Keywords
- Hydronephrosis, Laparoscopic, Pyeloplasty, Minimally invasive, Ureteropelvic junction obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ureteropelvic junction obstruction | – | Procedure: One-trocar-assisted pyeloplastyUPJO 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%. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-trocar-assisted pyeloplastyPositioned 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. | Procedure or surgery | Ureteropelvic junction obstruction |
Primary outcome
Operative time
Time frame: through study completion (3 years)
The average and range of operative time (minutes) using the OTAP technique
Conversion to open
Time frame: through study completion (3 years)
Incidence in which the operation must be switch to open surgery
Extension of skin incision
Time frame: through study completion (3 years)
Incidence in which the original incision of the skin must be extended to accommodate UPJ mobilization
Postoperative complications
Time frame: through study completion (3 years)
Complications after OTAP including febrile UTI
Median length of hospital stays
Time frame: through study completion (3 years)
The average time (days) the patient stays at the hospital post-operation
Median follow up length
Time frame: through study completion (3 years)
The average time (months) the patient revisit the hospital for follow-up sessions
Post-operative mean APD
Time frame: through study completion (3 years)
The average anterior posterior diameter (mm) of the renal pelvis post-operation
Post-operative mean DRF
Time frame: through study completion (3 years)
The average different renal function (%) (measurement of each kidney's ability to extract tracer from blood) after the operation
Mean incision length
Time frame: through study completion (3 years)
The average length (mm) of the primary incision during the operation
Recurrence
Time frame: through study completion (3 years)
Instances of symptoms reappeared after the completion of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 18148283ANDERSON JC, HYNES W. Retrocaval ureter; a case diagnosed pre-operatively and treated successfully by a plastic operation. Br J Urol. 1949 Sep;21(3):209-14. doi: 10.1111/j.1464-410x.1949.tb10773.x. No abstract available.
- Background: PubMed 1393432Mikkelsen SS, Rasmussen BS, Jensen TM, Hanghoj-Petersen W, Christensen PO. Long-term follow-up of patients with hydronephrosis treated by Anderson-Hynes pyeloplasty. Br J Urol. 1992 Aug;70(2):121-4. doi: 10.1111/j.1464-410x.1992.tb15688.x.
- Background: PubMed 8230507Schuessler WW, Grune MT, Tecuanhuey LV, Preminger GM. Laparoscopic dismembered pyeloplasty. J Urol. 1993 Dec;150(6):1795-9. doi: 10.1016/s0022-5347(17)35898-6.
- Background: PubMed 15720343Inagaki T, Rha KH, Ong AM, Kavoussi LR, Jarrett TW. Laparoscopic pyeloplasty: current status. BJU Int. 2005 Mar;95 Suppl 2:102-5. doi: 10.1111/j.1464-410X.2005.05208.x.
- Background: PubMed 19914659Braga LH, Lorenzo AJ, Bagli DJ, Mahdi M, Salle JL, Khoury AE, Farhat WA. Comparison of flank, dorsal lumbotomy and laparoscopic approaches for dismembered pyeloplasty in children older than 3 years with ureteropelvic junction obstruction. J Urol. 2010 Jan;183(1):306-11. doi: 10.1016/j.juro.2009.09.008.
- Background: PubMed 21284513Sweeney DD, Ost MC, Schneck FX, Docimo SG. Laparoscopic pyeloplasty for ureteropelvic junction obstruction in children. J Laparoendosc Adv Surg Tech A. 2011 Apr;21(3):261-5. doi: 10.1089/lap.2010.0155. Epub 2011 Feb 1.
- Background: PubMed 17707047Piaggio LA, Franc-Guimond J, Noh PH, Wehry M, Figueroa TE, Barthold J, Gonzalez R. Transperitoneal laparoscopic pyeloplasty for primary repair of ureteropelvic junction obstruction in infants and children: comparison with open surgery. J Urol. 2007 Oct;178(4 Pt 2):1579-83. doi: 10.1016/j.juro.2007.03.159. Epub 2007 Aug 16.
- Background: PubMed 14633078Hemal AK, Goel R, Goel A. Cost-effective laparoscopic pyeloplasty: single center experience. Int J Urol. 2003 Nov;10(11):563-8. doi: 10.1046/j.1442-2042.2003.00706.x.
- Background: PubMed 28365863Boysen WR, Gundeti MS. Robot-assisted laparoscopic pyeloplasty in the pediatric population: a review of technique, outcomes, complications, and special considerations in infants. Pediatr Surg Int. 2017 Sep;33(9):925-935. doi: 10.1007/s00383-017-4082-7. Epub 2017 Apr 1.
- Background: PubMed 19476793Passerotti CC, Passerotti AM, Dall'Oglio MF, Leite KR, Nunes RL, Srougi M, Retik AB, Nguyen HT. Comparing the quality of the suture anastomosis and the learning curves associated with performing open, freehand, and robotic-assisted laparoscopic pyeloplasty in a swine animal model. J Am Coll Surg. 2009 Apr;208(4):576-86. doi: 10.1016/j.jamcollsurg.2009.01.010.
- Background: PubMed 29264208Howe A, Kozel Z, Palmer L. Robotic surgery in pediatric urology. Asian J Urol. 2017 Jan;4(1):55-67. doi: 10.1016/j.ajur.2016.06.002. Epub 2016 Sep 6.
- Background: PubMed 28426695Song SH, Lee C, Jung J, Kim SJ, Park S, Park H, Kim KS. A comparative study of pediatric open pyeloplasty, laparoscopy-assisted extracorporeal pyeloplasty, and robot-assisted laparoscopic pyeloplasty. PLoS One. 2017 Apr 20;12(4):e0175026. doi: 10.1371/journal.pone.0175026. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quang T Nguyen, M.D. principal investigator
: Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteropelvic Junction Obstruction, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: through study completion (3 years)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349161, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.