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

Ureteropelvic Junction Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06349161
• Other study ID #: 1451_02/BVNTW-VNCSKTE
• Status: Completed
• Start date: May 2011
• Est. completion date: March 2024

Study information

• Verified date: March 2024
• Source: National Children's Hospital, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2024
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydronephrosis
• Multicystic Dysplastic Kidney
• Ureteral Obstruction
• Ureteropelvic Junction Obstruction

Intervention

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.

Locations

Country	Name	City	State
Vietnam	The National Hospital of Pediatrics	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
National Children's Hospital, Vietnam

Country where clinical trial is conducted

Vietnam, 

References & Publications (27)

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Bajpai M, Khanna K, Khanna V, Goel P, Baidya DK. Lumboscopic-Assisted Pyeloplasty: A Single-Port, Retroperitoneoscopic Approach for Children with Pelvi-Ureteric Junction Obstruction. J Indian Assoc Pediatr Surg. 2020 May-Jun;25(3):163-168. doi: 10.4103/ji — View Citation

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Boysen WR, Gundeti MS. Robot-assisted laparoscopic pyeloplasty in the pediatric population: a review of technique, outcomes, complications, and special considerations in infants. Pediatr Surg Int. 2017 Sep;33(9):925-935. doi: 10.1007/s00383-017-4082-7. Epub 2017 Apr 1. Erratum In: Pediatr Surg Int. 2017 Jun 19;: — View Citation

Braga LH, Lorenzo AJ, Bagli DJ, Mahdi M, Salle JL, Khoury AE, Farhat WA. Comparison of flank, dorsal lumbotomy and laparoscopic approaches for dismembered pyeloplasty in children older than 3 years with ureteropelvic junction obstruction. J Urol. 2010 Jan;183(1):306-11. doi: 10.1016/j.juro.2009.09.008. — View Citation

Caione P, Lais A, Nappo SG. One-port retroperitoneoscopic assisted pyeloplasty versus open dismembered pyeloplasty in young children: preliminary experience. J Urol. 2010 Nov;184(5):2109-15. doi: 10.1016/j.juro.2010.06.126. Epub 2010 Sep 18. — View Citation

Chen WC, Huang SY, Yeh CM, Chou CM. Hybrid Retroperitoneoscopic Pyeloplasty for Congenital Ureteropelvic Junction Obstruction in Infants Weighing Less than 10 kg. J Laparoendosc Adv Surg Tech A. 2021 Jul;31(7):843-848. doi: 10.1089/lap.2020.0799. Epub 202 — View Citation

Chen Z, Chen X, Wu ZH, Luo YC, He Y, Li NN, Xie CQ, Lai C. Feasibility and safety of retroperitoneal laparoendoscopic single-site dismembered pyeloplasty: a clinical report of 10 cases. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):685-90. doi: 10.1089/l — View Citation

He Y, Song H, Liu P, Sun N, Tian J, Li M, Li N, Qu Y, Han W, Feng G, Ni X, Zhang W. Primary laparoscopic pyeloplasty in children: A single-center experience of 279 patients and analysis of possible factors affecting complications. J Pediatr Urol. 2020 Jun — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	The average and range of operative time (minutes) using the OTAP technique	through study completion (3 years)
Primary	Conversion to open	Incidence in which the operation must be switch to open surgery	through study completion (3 years)
Primary	Extension of skin incision	Incidence in which the original incision of the skin must be extended to accommodate UPJ mobilization	through study completion (3 years)
Primary	Postoperative complications	Complications after OTAP including febrile UTI	through study completion (3 years)
Primary	Median length of hospital stays	The average time (days) the patient stays at the hospital post-operation	through study completion (3 years)
Primary	Median follow up length	The average time (months) the patient revisit the hospital for follow-up sessions	through study completion (3 years)
Primary	Post-operative mean APD	The average anterior posterior diameter (mm) of the renal pelvis post-operation	through study completion (3 years)
Primary	Post-operative mean DRF	The average different renal function (%) (measurement of each kidney's ability to extract tracer from blood) after the operation	through study completion (3 years)
Primary	Mean incision length	The average length (mm) of the primary incision during the operation	through study completion (3 years)
Primary	Recurrence	Instances of symptoms reappeared after the completion of the surgery	through study completion (3 years)