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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05748964

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases Surgery	Procedure: Laparoscopic pyeloplasty

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Transperitoneal approach laparoscopic pyeloplasty. (TALP) Transperitoneal approach laparoscopic pyeloplasty. (TALP)	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.
Retroperitoneal Approach laparoscopic pyeloplasty. (RALP) Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)	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.

Arm

Intervention/Treatment

Transperitoneal approach laparoscopic pyeloplasty. (TALP)

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.

Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)

Procedure: Laparoscopic pyeloplasty

Outcome Measures

Primary Outcome Measures

Operative time [From April 1, 2023 to April 1, 2024]
Operative time

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Age above two years.
Unilateral UPJO.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Kamel Ali Mohamed, Mr., Assiut University

ClinicalTrials.gov Identifier:

NCT05748964

Other Study ID Numbers:

AKA1712

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Kamel Ali Mohamed, Mr., Assiut University

UPJ obstruction

pediatric urology

pyeloplasty

Additional relevant MeSH terms:

Urologic Diseases

Study Results

No Results Posted as of Mar 1, 2023