One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication

March 31, 2024 updated by: Nguyen Thanh Quang, National Children's Hospital, Vietnam
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • The National Hospital of Pediatrics
      • Hanoi, Vietnam
        • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Children's Hospital, Vietnam

Collaborators

Vinmec Research Institute of Stem Cell and Gene Technology

Investigators

  • Principal Investigator: Quang T Nguyen, M.D., : Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1451_01/BVNTW-VNCSKTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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