Clinical trial NCT06350942: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication
Official title: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Duplication
Keywords: Duplex Kidney
Ureteral Duplication
Ureteroureterostomy
Retroperitoneoscopic
Single-trocar
Lead sponsor: National Children's Hospital, Vietnam
Sponsor class: OTHER
Collaborators: name: Vinmec Research Institute of Stem Cell and Gene Technology
First posted: 2024-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients diagnosed with ureteral duplication, including with either ectopic or obstructed ureter, were treated with OTAU between September 2016 and December 2020. Preoperative diagnostic evaluations included blood tests, urinalysis, culture, renal ultrasonography (US), and voiding cystourethrogram to identify vesicoureteral reflux. Dimercaptosuccinic acid (DMSA) scintigraphy was used to measure the differential renal function (DRF). UU was performed irrespective of the differential function of the upper pole moiety (UPM) or the patient's age.

Brief summary: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children.

Detailed description: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children.

Demographic data of patients, their clinical manifestations, classification of hydronephrosis based on the guidelines established by the Society for Fetal Urology (SFU), dimensions of the renal pelvis measured in the anterior-posterior direction (APD), diameters of the ureters, duration of surgical procedures, duration of hospitalization, and subsequent follow-up information were systematically gathered prospectively to evaluate the long-term outcomes of the proposing surgical technique.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ureteral duplication.
* Age no more than 18 years old
* The surgical technique performed must be one trocar-assisted retroperitoneoscopic ureteroureterostomy.
* Followed up at least 2-4 years

Exclusion Criteria:

* Patients exhibiting reflux to the ureter of the lower pole moiety (LPM)
* Patients with prior urologic surgeries or other urological anomalies

Primary outcomes:
measure: Mean operating time
timeFrame: through study completion (4 years)
measure: Intraoperative complications
timeFrame: through study completion (4 years)
measure: Conversion to open
timeFrame: through study completion (4 years)
measure: Early postoperative complications
timeFrame: through study completion (4 years)
measure: Median length of hospital stays
timeFrame: through study completion (4 years)
measure: Mean UPM renal pelvis' APD
timeFrame: through study completion (4 years)
measure: Mean SFU of UPM renal pelvis
timeFrame: through study completion (4 years)
measure: Mean UPM ureter's diameter
timeFrame: through study completion (4 years)
measure: Mean UPM DRF
timeFrame: through study completion (4 years)
measure: Mean DRF of operated side
timeFrame: through study completion (4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: The National Hospital of Pediatrics
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: : Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
name: Quang T Nguyen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glassberg KI, Braren V, Duckett JW, Jacobs EC, King LR, Lebowitz RL, Perlmutter AD, Stephens FD. Suggested terminology for duplex systems, ectopic ureters and ureteroceles. J Urol. 1984 Dec;132(6):1153-4. doi: 10.1016/s0022-5347(17)50072-5.
citation: Chacko JK, Koyle MA, Mingin GC, Furness PD 3rd. Ipsilateral ureteroureterostomy in the surgical management of the severely dilated ureter in ureteral duplication. J Urol. 2007 Oct;178(4 Pt 2):1689-92. doi: 10.1016/j.juro.2007.05.098. Epub 2007 Aug 17.
citation: Fernbach SK, Feinstein KA, Spencer K, Lindstrom CA. Ureteral duplication and its complications. Radiographics. 1997 Jan-Feb;17(1):109-27. doi: 10.1148/radiographics.17.1.9017803.
citation: Stokland E, Jodal U, Sixt R, Swerkersson S, Hansson S. Uncomplicated duplex kidney and DMSA scintigraphy in children with urinary tract infection. Pediatr Radiol. 2007 Aug;37(8):826-8. doi: 10.1007/s00247-007-0518-x. Epub 2007 Jun 26.
citation: Timberlake MD, Corbett ST. Minimally invasive techniques for management of the ureterocele and ectopic ureter: upper tract versus lower tract approach. Urol Clin North Am. 2015 Feb;42(1):61-76. doi: 10.1016/j.ucl.2014.09.006. Epub 2014 Oct 11.
citation: McLeod DJ, Alpert SA, Ural Z, Jayanthi VR. Ureteroureterostomy irrespective of ureteral size or upper pole function: a single center experience. J Pediatr Urol. 2014 Aug;10(4):616-9. doi: 10.1016/j.jpurol.2014.05.003. Epub 2014 Jun 2.
citation: Lashley DB, McAleer IM, Kaplan GW. Ipsilateral ureteroureterostomy for the treatment of vesicoureteral reflux or obstruction associated with complete ureteral duplication. J Urol. 2001 Feb;165(2):552-4. doi: 10.1097/00005392-200102000-00067.
citation: Prieto J, Ziada A, Baker L, Snodgrass W. Ureteroureterostomy via inguinal incision for ectopic ureters and ureteroceles without ipsilateral lower pole reflux. J Urol. 2009 Apr;181(4):1844-8; discussion 1848-50. doi: 10.1016/j.juro.2008.12.004. Epub 2009 Feb 23.
citation: Cundy TP, Shetty K, Clark J, Chang TP, Sriskandarajah K, Gattas NE, Najmaldin A, Yang GZ, Darzi A. The first decade of robotic surgery in children. J Pediatr Surg. 2013 Apr;48(4):858-65. doi: 10.1016/j.jpedsurg.2013.01.031.
citation: Herz D, Smith J, McLeod D, Schober M, Preece J, Merguerian P. Robot-assisted laparoscopic management of duplex renal anomaly: Comparison of surgical outcomes to traditional pure laparoscopic and open surgery. J Pediatr Urol. 2016 Feb;12(1):44.e1-7. doi: 10.1016/j.jpurol.2015.04.046. Epub 2015 Aug 17.
citation: Wong NC, Braga LH. Open ureteroureterostomy for repair of upper-pole ectopic ureters in children with duplex systems: is stenting really necessary? J Pediatr Urol. 2019 Feb;15(1):72.e1-72.e7. doi: 10.1016/j.jpurol.2018.10.014. Epub 2018 Oct 24.
citation: Gonzalez R, Piaggio L. Initial experience with laparoscopic ipsilateral ureteroureterostomy in infants and children for duplication anomalies of the urinary tract. J Urol. 2007 Jun;177(6):2315-8. doi: 10.1016/j.juro.2007.01.177.
citation: Lowe GJ, Canon SJ, Jayanthi VR. Laparoscopic reconstructive options for obstruction in children with duplex renal anomalies. BJU Int. 2008 Jan;101(2):227-30. doi: 10.1111/j.1464-410X.2007.07106.x. Epub 2007 Sep 13.
citation: Chandrasekharam V, Jayaram H. Laparoscopic ipsilateral ureteroureterostomy for the management of children with duplication anomalies. J Indian Assoc Pediatr Surg. 2015 Jan;20(1):27-31. doi: 10.4103/0971-9261.145442.
citation: Storm DW, Modi A, Jayanthi VR. Laparoscopic ipsilateral ureteroureterostomy in the management of ureteral ectopia in infants and children. J Pediatr Urol. 2011 Oct;7(5):529-33. doi: 10.1016/j.jpurol.2010.08.004. Epub 2010 Sep 25.
citation: Lee NG, Corbett ST, Cobb K, Bailey GC, Burns AS, Peters CA. Bi-Institutional Comparison of Robot-Assisted Laparoscopic Versus Open Ureteroureterostomy in the Pediatric Population. J Endourol. 2015 Nov;29(11):1237-41. doi: 10.1089/end.2015.0223. Epub 2015 Aug 21.
citation: Kawal T, Srinivasan AK, Talwar R, Chu DI, Long C, Weiss D, Van Batavia J, Kolon TF, Shukla AR. Ipsilateral ureteroureterostomy: does function of the obstructed moiety matter? J Pediatr Urol. 2019 Feb;15(1):50.e1-50.e6. doi: 10.1016/j.jpurol.2018.08.012. Epub 2018 Aug 20.
citation: Biles MJ, Finkelstein JB, Silva MV, Lambert SM, Casale P. Innovation in Robotics and Pediatric Urology: Robotic Ureteroureterostomy for Duplex Systems with Ureteral Ectopia. J Endourol. 2016 Oct;30(10):1041-1048. doi: 10.1089/end.2015.0645. Epub 2016 Sep 16.
citation: Liem NT, Dung LA, Viet ND. Single trocar retroperitoneoscopic assisted ipsilateral ureteroureterostomy for ureteral duplication. Pediatr Surg Int. 2012 Oct;28(10):1031-4. doi: 10.1007/s00383-012-3158-7. Epub 2012 Aug 12.
citation: Grimsby GM, Merchant Z, Jacobs MA, Gargollo PC. Laparoscopic-assisted ureteroureterostomy for duplication anomalies in children. J Endourol. 2014 Oct;28(10):1173-7. doi: 10.1089/end.2014.0113. Epub 2014 Aug 13.
citation: Bieri M, Smith CK, Smith AY, Borden TA. Ipsilateral ureteroureterostomy for single ureteral reflux or obstruction in a duplicate system. J Urol. 1998 Mar;159(3):1016-8.