One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication

Completed

• Conditions: Ureteral Duplication
• Interventions: Procedure: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU)

• Registration Number: NCT06350942
• Lead Sponsor: National Children's Hospital, Vietnam

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2020-12
• Study Completion: 2024-02
• Status Verified: 2024-03
• Study First Submitted: 2024-03-30
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complete duplicated collecting system	one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU)	The presence of two pelvicalyceal systems within a single kidney, with either obstructed or ectopic ureter

Primary Outcome Measures

Name	Time	Method
Intraoperative complications	through study completion (4 years)	Complications experienced during the procedure
Mean operating time	through study completion (4 years)	The average operating time (minutes) of OTAU
Conversion to open	through study completion (4 years)	Incidence in which the operation must be switch to open surgery
Median length of hospital stays	through study completion (4 years)	Average time (days) the patient has to stay at the hospital post-operation
Mean SFU of UPM renal pelvis	through study completion (4 years)	The average Society of Fetal Urology classification of the upper pole moiety before and after the operation
Mean UPM renal pelvis' APD	through study completion (4 years)	The average anterior-posterior diameter (mm) of the upper pole moiety before and after the operation
Early postoperative complications	through study completion (4 years)	Complications after OTAU including UTI and wound infection
Mean UPM DRF	through study completion (4 years)	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
Mean UPM ureter's diameter	through study completion (4 years)	The average ureter's diameter (mm) of the upper pole moiety before and after the operation
Mean DRF of operated side	through study completion (4 years)	The average differential renal function (%) of the operated side before and after operation

Trial Locations

Locations (2)

The National Hospital of Pediatrics; 🇻🇳 Hanoi, Vietnam

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam