One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication

NCT06350942 | Completed

• 1 other identifier: 1451_01/BVNTW-VNCSKTE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Ureteral Duplication

Keywords

Duplex Kidney; Ureteral Duplication; Ureteroureterostomy; Retroperitoneoscopic; Single-trocar

Outcome Measures

Primary Outcomes (10)

• Mean operating time

  The average operating time (minutes) of OTAU

  through study completion (4 years)

• Intraoperative complications

  Complications experienced during the procedure

  through study completion (4 years)

• Conversion to open

  Incidence in which the operation must be switch to open surgery

  through study completion (4 years)

• Early postoperative complications

  Complications after OTAU including UTI and wound infection

  through study completion (4 years)

• Median length of hospital stays

  Average time (days) the patient has to stay at the hospital post-operation

  through study completion (4 years)

• Mean UPM renal pelvis' APD

  The average anterior-posterior diameter (mm) of the upper pole moiety before and after the operation

  through study completion (4 years)

• Mean SFU of UPM renal pelvis

  The average Society of Fetal Urology classification of the upper pole moiety before and after the operation

  through study completion (4 years)

• Mean UPM ureter's diameter

  The average ureter's diameter (mm) of the upper pole moiety before and after the operation

  through study completion (4 years)

• Mean UPM DRF

  The average differential renal function (%) (measurement of each kidney's ability to extract tracer from blood) of the upper pole moiety before and after operation

  through study completion (4 years)

• Mean DRF of operated side

  The average differential renal function (%) of the operated side before and after operation

  through study completion (4 years)

Study Arms (1)

Complete duplicated collecting system

The presence of two pelvicalyceal systems within a single kidney, with either obstructed or ectopic ureter

Procedure: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU)

Interventions

one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU) PROCEDURE

A 12 mm transverse incision was made just above the iliac crest, followed by careful dissection of the fascia and muscle layer to expose the Gerota's fascia. Entry into the retroperitoneal space was achieved with a 10-mm balloon trocar, allowing for pneumoretroperitoneum establishment. Using a 10-mm laparoscope equipped with a Maryland dissector, the ureters were dissected and isolated, followed by careful exteriorization of both upper and lower pole moiety ureters with a Babcock grasper. The pathological upper pole moiety ureter was transected, preserving the normal lower pole moiety ureter and shared blood supply, and closed with a Vicryl 4/0 suture. Subsequently, an end-to-side ureteroureterostomy was performed with a 6/0 Polydioxanone running suture, with antegrade insertion of a double J stent if not previously conducted. A final retroperitoneoscopic evaluation ensured proper anastomosis alignment, and the incision was closed without drainage.

Complete duplicated collecting system

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead
• Vinmec Research Institute of Stem Cell and Gene Technology: collaborator

Study Sites (2)

The National Hospital of Pediatrics

Hanoi, Vietnam

Location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Location

Related Publications (21)

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  PMID: 17509348 RESULT

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• 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.

  PMID: 9474221 RESULT

Study Officials

• Quang T Nguyen, M.D.

  : Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Surgeon

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 8, 2024
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)