Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO

June 7, 2023 updated by: Ahmed Rammah, Cairo University

Functional Outcome After Laparoscopic and Robot Assisted Management of Uretero-pelvic Junction Obstruction Disease Caused by Crossing Vessels for Adult Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vascular hitch
displacement of the lower polar crossing vessels causing the UPJO
Procedure: pyeloplasty
repair of the uPJO
Active Comparator: Dismembered pyeloplasty
classic Anderson-Hynes procedure
Procedure: pyeloplasty
repair of the uPJO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparing the two techniques regarding the success rate
Time Frame: 2 years
both techniques are supposed to have similar results
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-85-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the researchers would determine whether they would share or not during the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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