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NCT05748964 Clinical Trial

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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05748964
Other study ID # AKA1712
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date June 1, 2025

Study information
Verified date February 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 1, 2025
Est. primary completion date April 1, 2024
Accepts healthy volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic pyeloplasty
Twenty patients presented with ureteropelvic junction obstruction [UPJO] will be divided into two equal groups. The first was subjected to trans-peritoneal pyeloplasty while the second was subjected to retroperitoneal pyeloplasty.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Operative time Operative time From April 1, 2023 to April 1, 2024
Secondary Convergence rate Convergence to open pyeloplasty From April 1, 2023 to April 1, 2024
Secondary Post operative complications Post operative complications From April 1, 2023 to April 1, 2024
Secondary Hospital stay Hospital stay From April 1, 2023 to April 1, 2024
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