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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

70

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

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

The cohort comprised seventy pediatric patients who underwent RALP for UPJO at the National Hospital of Pediatrics between May 2011 and June 2013. Preoperative diagnostic evaluations included blood tests, urinalysis, urine culture, renal ultrasonography (US), voiding cystourethrogram (VCUG) to exclude vesicoureteral reflux disease, magnetic resonance imaging (MRI) to exclude other associated renal pathologies, and technetium-99m diethylenetriamine penta-acetic acid (99mTc DTPA) scans.

Description

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.

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
Ureteropelvic junction obstruction
UPJO with severe hydronephrosis, with or without parenchymal atrophy (Society for Fetal Urology grade III or IV), recurrent urinary tract infections (UTI), prolonged drainage parameters with T1/2 > 20 minutes, and/or differential renal function (DRF) less than 40%.
Procedure: One-trocar-assisted pyeloplasty
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: through study completion (3 years)
The average and range of operative time (minutes) using the OTAP technique
through study completion (3 years)
Conversion to open
Time Frame: through study completion (3 years)
Incidence in which the operation must be switch to open surgery
through study completion (3 years)
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
through study completion (3 years)
Postoperative complications
Time Frame: through study completion (3 years)
Complications after OTAP including febrile UTI
through study completion (3 years)
Median length of hospital stays
Time Frame: through study completion (3 years)
The average time (days) the patient stays at the hospital post-operation
through study completion (3 years)
Median follow up length
Time Frame: through study completion (3 years)
The average time (months) the patient revisit the hospital for follow-up sessions
through study completion (3 years)
Post-operative mean APD
Time Frame: through study completion (3 years)
The average anterior posterior diameter (mm) of the renal pelvis post-operation
through study completion (3 years)
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
through study completion (3 years)
Mean incision length
Time Frame: through study completion (3 years)
The average length (mm) of the primary incision during the operation
through study completion (3 years)
Recurrence
Time Frame: through study completion (3 years)
Instances of symptoms reappeared after the completion of the surgery
through study completion (3 years)

Collaborators and Investigators

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

Sponsor

National Children's Hospital, Vietnam

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)

May 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1451_02/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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