Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO

NCT ID: NCT05895422

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-07-01

Brief Summary

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an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch.

Detailed Description

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in recent studies, some patients with crossing vessels UPJO could be managed by vascular displacement of these vessels, what is named as vascular hitch or vasculopexy in a way to avoid classic dismembered technique. this newer technique is supposed to provide comparable results to the classic technique but with lesser operative time and shorter hospital stay. in the era of minimally invasive procedures, robotic assisted or laparoscopic vascular hitch could provide many advantages over the classic open technique.

Conditions

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Ureteropelvic Junction Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized intervention study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
one blind

Study Groups

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vascular hitch

displacement of the lower polar crossing vessels causing the UPJO

Group Type EXPERIMENTAL

pyeloplasty

Intervention Type PROCEDURE

repair of the uPJO

Dismembered pyeloplasty

classic Anderson-Hynes procedure

Group Type ACTIVE_COMPARATOR

pyeloplasty

Intervention Type PROCEDURE

repair of the uPJO

Interventions

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pyeloplasty

repair of the uPJO

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all patients with UPJO above 18 years
* UPJO caused by crossing vessels confirmed by CT angiography
* Symptomatic UPJO

Exclusion Criteria

* recurrent UPJO after a previous trial of open repair ,
* secondary UPJO after open renal surgery.
* UPJO in non functioning kidney
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Rammah

lecturer of urology- faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M Rammah, MD

Role: CONTACT

2001005622939

Islam N Abdel Aziz, M.sc

Role: CONTACT

2001013132994

Facility Contacts

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Ahmed M Rammah, MD

Role: primary

2001005622939

Islam N Abdel AZIA, M.sc

Role: backup

2001013132994

Other Identifiers

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MD-85-2023

Identifier Type: -

Identifier Source: org_study_id

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