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Completed

NCT Number: NCT06349161

Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience

Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature.

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Key information

Conditions

Ureteropelvic Junction Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydronephrosis Kidney Diseases Male Urogenital Diseases Multicystic renal dysplasia, bilateral Urogenital Diseases Urologic Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The National Hospital of Pediatrics

Hanoi, Vietnam

About this study

Open surgical dismembered pyeloplasty has historically been the gold standard for managing ureteropelvic junction obstruction (UPJO), boasting a success rate exceeding 94%. However, the requisite incision and muscle dissection can lead to increased postoperative pain, prolonged hospitalization, and undesirable scarring. In recent decades, there has been a growing interest in minimally invasive pyeloplasty, commencing with its inception in 1993. Laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP) have emerged as widely embraced and dependable therapeutic modalities for UPJO. Both techniques have demonstrated success rates comparable to those of open pyeloplasty while conferring advantages in terms of cosmetic outcomes and length of hospital stay.

However, despite their merits, minimally invasive approaches pose certain limitations in pediatric patients, including restricted working space, technical intricacies, prolonged operative time, steep learning curves, and the need for expensive instrumentation. Conventional laparoscopic pyeloplasty has encountered slow uptake due to its technical demands and substantial learning curve. The evolution of RALP over the past decade appears to mitigate the learning curve associated with intracorporeal suturing and anastomosis time. Nonetheless, RALP necessitates three to four port placements and a sizeable initial financial investment.

In 2007, Lima et al. introduced the retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) approach, which "combines the advantages of a minimally invasive technique with the high success rate of standard dismembered pyeloplasty". Several other researchers have replicated this technique with favorable outcomes. Nevertheless, a dearth of comprehensive studies delineating long-term follow-up and clinical outcomes persists in the medical literature. The aim of this study is to evaluate the long-term outcomes of OTAP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children 6 months to 5 years old with UPJ obstruction who underwent OTAP between May 2011 and June 2013.
  • Anteroposterior renal pelvic diameter of 20 mm or greater, which demonstrated progressive enlargement on subsequent ultrasounds, coupled with impaired split renal function of 40% or less on nuclear scan, characterized by a T1/2 > 20 minutes
  • The surgical technique performed must be one trocar-assisted pyeloplasty

Exclusion criteria

  • A history of previous renal surgery
  • UPJO associated with other urinary tract anomalies
  • Identification of crossing lower pole renal vessels as the cause of obstruction.

Treatment and study plan

One-trocar-assisted pyeloplasty

Procedure

Positioned in a full lateral decubitus posture. A 12mm incision was made below the 12th rib, followed by a muscle-sparing technique to access and open the Gerota's fascia. A 10mm balloon trocar was inserted, and CO2 was insufflated to a pressure of 12 mmHg at a flow rate of 3L. An operative scope with dual channels was introduced for retroperitoneal dissection, utilizing a peanut to expand the working space. The proximal ureter, UPJ, and renal pelvis were visualized, and the UPJ was mobilized and exteriorized under direct visualization to prevent torsion. Anderson-Hynes dismembered pyeloplasty was performed using a 6/0 PDS suture, with possible enlargement of the incision if necessary. A 4 French double J ureteral stent was inserted antegradely before completing the anastomosis, verified by methylene blue presence at the anastomotic site. A final retroperitoneoscopic assessment ensured proper alignment of the anastomosis, with closure of the incision site without drain placement.

Primary outcomes

  1. Operative time

    Time frame: through study completion (3 years)

    The average and range of operative time (minutes) using the OTAP technique

  2. Conversion to open

    Time frame: through study completion (3 years)

    Incidence in which the operation must be switch to open surgery

  3. Extension of skin incision

    Time frame: through study completion (3 years)

    Incidence in which the original incision of the skin must be extended to accommodate UPJ mobilization

  4. Postoperative complications

    Time frame: through study completion (3 years)

    Complications after OTAP including febrile UTI

  5. Median length of hospital stays

    Time frame: through study completion (3 years)

    The average time (days) the patient stays at the hospital post-operation

  6. Median follow up length

    Time frame: through study completion (3 years)

    The average time (months) the patient revisit the hospital for follow-up sessions

  7. Post-operative mean APD

    Time frame: through study completion (3 years)

    The average anterior posterior diameter (mm) of the renal pelvis post-operation

  8. Post-operative mean DRF

    Time frame: through study completion (3 years)

    The average different renal function (%) (measurement of each kidney's ability to extract tracer from blood) after the operation

  9. Mean incision length

    Time frame: through study completion (3 years)

    The average length (mm) of the primary incision during the operation

  10. Recurrence

    Time frame: through study completion (3 years)

    Instances of symptoms reappeared after the completion of the surgery

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Apr 5, 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.

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