Kidney TransplantationNCT06735066
Abnormalities of Preoperative Ascending Urethrocystography and Outcomes of Living Donor Kidney Transplantation
An observational study of Kidney Transplantation, run by Assiut University.
Trial summary
To evaluate effects of abnormalities in preoperative ascending urethrocystography on the short-term outcomes of LDKT Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Ascending urethrocystography
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult patients who underwent kidney transplantation
Who may be able to join
- Pediatric and adult patients undergoing LDKT in Assiut Kidney Transplantation Unit.
- Patients with preoperative evaluation by AUC.
Who cannot join
- Patients with a primary non-functioning graft after LDKT.
- Patients with missing relevant preoperative or postoperative data.
- Patients refusal to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Conditions
- Kidney Transplantation
- Being tested
- Ascending urethrocystography
- Keywords
- preoperative ascending urethrocystography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascending urethrocystographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transplantation group | adult patients who underwent kidney transplantation Receives: Procedure: Ascending urethrocystography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of urinary complications post kidney transplantation
Each patient will be followed up for the surgical complications for 6- month duration after KT
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study startDec 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehabeldin Alaa Ahmed Mahmoud Ahmed Saad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735066
- Sponsor's protocol ID
- Kidney transplantation 2024
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36168334Jayanth 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.
PubMed 30692727Freitas 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.
PubMed 36959709Sellers 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.
PubMed 15591958
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abnormalities of Preoperative Ascending Urethrocystography on the Short-term Outcomes of Living Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06735066
- Acronym / sponsor ID
- Kidney transplantation 2024
- Conditions
- Kidney Transplantation
- Keywords
- preoperative ascending urethrocystography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate effects of abnormalities in preoperative ascending urethrocystography on the short-term outcomes of LDKT
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplantation group | – | Procedure: Ascending urethrocystographyadult patients who underwent kidney transplantation |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult patients who underwent kidney transplantation
Key inclusion criteria (2 listed)
- Pediatric and adult patients undergoing LDKT in Assiut Kidney Transplantation Unit.
- Patients with preoperative evaluation by AUC.
Key exclusion criteria (3 listed)
- Patients with a primary non-functioning graft after LDKT.
- Patients with missing relevant preoperative or postoperative data.
- Patients refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascending urethrocystographyIt 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. | Procedure or surgery | Transplantation group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 36168334John 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.
- Results publication: PubMed 30692727Jayanth 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.
- Results publication: PubMed 36959709Freitas 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.
- Results publication: PubMed 15591958Sellers 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shehabeldin Saad (+201067076462, shehab.16266285@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of urinary complications post kidney transplantation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06735066, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.