Abnormalities of Preoperative Ascending Urethrocystography and Outcomes of Living Donor Kidney Transplantation

December 11, 2024 updated by: Shehabeldin Alaa Ahmed Mahmoud Ahmed Saad, Assiut University

Effects of Abnormalities of Preoperative Ascending Urethrocystography on the Short-term Outcomes of Living Donor Kidney Transplantation

To evaluate effects of abnormalities in preoperative ascending urethrocystography on the short-term outcomes of LDKT

Study Overview

Status

Not yet recruiting

Detailed Description

The incidence of surgical complications after kidney transplantation (KT) has decreased in recent decades due to improvements in surgical techniques and immunosuppression protocols. However, the preoperative abnormalities of the urinary tract may influence the outcomes of KT. Hence, the preoperative evaluation of the urinary tract is a critical step in the KT process to identify the potential risk factors for poor outcomes .

Ascending urethrocystography (AUC) is a key diagnostic tool to assess the integrity and functionality of the lower urinary tract . It provides detailed insights into the bladder, urethra, vesicoureteral valves, and surrounding structures, identifying any abnormalities that could pose risks during or after KT . Understanding this issue is crucial, as certain urological anomalies may predispose patients to complications such as urinary leaks, infections, or delayed graft function, potentially leading to poorer short-term outcomes .

Although AUC is used indiscriminately as a screening test for urological abnormalities, only 6% of all KT recipients may have abnormal lower urinary tract . Few studies have looked at the yield from AUC and attempted to assess objectively whether certain patients could be selected for KT based on a positive result in AUC . Accordingly, the impact of abnormalities detected in AUC on the short-term outcomes of living donor KT (LDKT) remains inefficiently studied .

This is the rationale to conduct this cohort study on patients undergoing LDKT. We hypothesize that the presence of abnormalities in AUC will influence the surgical outcomes and short-term survival rates after LDKT

Study Type

Observational

Enrollment (Estimated)

80

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

adult patients who underwent kidney transplantation

Description

Inclusion Criteria:

  • Pediatric and adult patients undergoing LDKT in Assiut Kidney Transplantation Unit.
  • Patients with preoperative evaluation by AUC.

Exclusion Criteria:

  • Patients with a primary non-functioning graft after LDKT.
  • Patients with missing relevant preoperative or postoperative data.
  • Patients refusal to participate in the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transplantation group
adult patients who underwent kidney transplantation

It will be performed after instructing the patient to evacuate the bladder. A contrast agent will be infused through the urethra under fluoroscopy, using a urethral catheter or Knutson's clamp at the external urethral meatus. When the bladder is full, an anteroposterior film and two oblique films will be taken. Voiding cystourethrography will be performed as a part of this imaging examination. From this procedure, the following findings may be diagnosed:

  • Upper urinary tract: Vesicoureteral reflux (VUR); laterality and degrees of VUR will be defined.
  • Bladder: Capacity (defunctionalized, Small-sized or contracted bladder), neurogenic bladder, bladder diverticulum, filling defects, etc.
  • Urethra: Stricture and filling defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of urinary complications post kidney transplantation
Time Frame: 6 month
Each patient will be followed up for the surgical complications for 6- month duration after KT
6 month

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kidney transplantation 2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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