- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06735066
Abnormalities of Preoperative Ascending Urethrocystography and Outcomes of Living Donor Kidney Transplantation
Effects of Abnormalities of Preoperative Ascending Urethrocystography on the Short-term Outcomes of Living Donor Kidney Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shehabeldin Saad
- Phone Number: +201067076462
- Email: shehab.16266285@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
|
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
Sponsor
Publications and helpful links
General Publications
- John EE, Mehta S, Sohal PM, Sandhu JS. Predictors of Short-Term Outcomes in Living Donor Renal Allograft Recipients: A Prospective Study From a Tertiary Care Center in North India. Cureus. 2022 Aug 24;14(8):e28335. doi: 10.7759/cureus.28335. eCollection 2022 Aug.
- Jayanth ST, Dangi AD, Mukha RP, Kumar S, Varughese S, David VG, Valson A, Chandrasingh J, Devasia A, Kekre N. Renal transplantation into optimized abnormal lower urinary tract - Impact on graft outcomes, patient survival, and complications. Indian J Urol. 2019 Jan-Mar;35(1):67-72. doi: 10.4103/iju.IJU_203_18.
- Freitas PS, Alves AS, Correia PS, Dias JL. Urethrocystography: a guide for urological surgery? Diagn Interv Radiol. 2023 Jan 31;29(1):9-17. doi: 10.5152/dir.2022.21640. Epub 2022 Dec 21.
- Sellers MT, Velidedeoglu E, Bloom RD, Grossman RA, Markmann JW, Naji A, Frank AM, Kass AB, Nathan HM, Hasz RD, Abrams JD, Markmann JF. Expanded-criteria donor kidneys: a single-center clinical and short-term financial analysis--cause for concern in retransplantation. Transplantation. 2004 Dec 15;78(11):1670-5. doi: 10.1097/01.tp.0000144330.84573.66.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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