Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial

Not yet recruiting

• Conditions: Urologic Diseases; Surgery
• Interventions: Procedure: Laparoscopic pyeloplasty

• Registration Number: NCT05748964
• Lead Sponsor: Assiut University

Brief Summary

This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

Detailed Description

Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-18
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Study Start: 2023-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age above two years.
• Unilateral UPJO.

Exclusion Criteria

• Age below two years.
• Bilateral UPJO.
• Recurrent UPJO.
• Malrotated kidneys and renal fusion anomalies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transperitoneal approach laparoscopic pyeloplasty. (TALP)	Laparoscopic pyeloplasty	Transperitoneal approach laparoscopic pyeloplasty. (TALP)
Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)	Laparoscopic pyeloplasty	Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)

Primary Outcome Measures

Name	Time	Method
Operative time	From April 1, 2023 to April 1, 2024	Operative time

Secondary Outcome Measures

Name	Time	Method
Convergence rate	From April 1, 2023 to April 1, 2024	Convergence to open pyeloplasty
Post operative complications	From April 1, 2023 to April 1, 2024	Post operative complications
Hospital stay	From April 1, 2023 to April 1, 2024	Hospital stay