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Completed

NCT Number: NCT06350942

One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication

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.

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Key information

Conditions

Ureteral Duplication

Age range

1 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The National Hospital of Pediatrics, Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean operating time

    Time frame: through study completion (4 years)

    The average operating time (minutes) of OTAU

  2. Intraoperative complications

    Time frame: through study completion (4 years)

    Complications experienced during the procedure

  3. Conversion to open

    Time frame: through study completion (4 years)

    Incidence in which the operation must be switch to open surgery

  4. Early postoperative complications

    Time frame: through study completion (4 years)

    Complications after OTAU including UTI and wound infection

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Collaborators

  • Vinmec Research Institute of Stem Cell and Gene Technology

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.