- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274943
End-to-Side Interrupted Versus Continuous Arterial Suturing in Living Donor Kidney Transplantation
Patterns Of End-To-Side Arterial Suturing To The Iliac Arteries In Living Donor Kidney Transplantation
Study Overview
Status
Detailed Description
This observational study evaluates whether different patterns of arterial suturing during kidney transplantation influence short-term graft function and vascular outcomes in adult living donor kidney recipients. The study compares interrupted versus continuous end-to-side arterial anastomosis to the iliac arteries using standardized surgical and postoperative care pathways.
The research is designed as a combined retrospective and prospective non-randomized comparative cohort study conducted at the Assiut Kidney Transplantation Unit, Assiut University Urology Hospital. Adult patients who underwent or will undergo living donor kidney transplantation from November 2015 onward are assigned to one of two exposure groups based on the arterial suturing pattern chosen by the operating surgeon, without protocol-driven randomization. Preoperative assessment follows national kidney transplantation guidelines and includes detailed history, physical examination, laboratory investigations, and multimodal imaging of donors and recipients. Intraoperative management is standardized regarding donor nephrectomy technique, transplant approach, vascular anastomosis sites, ureteroneocystostomy, ischemia time recording, and immunosuppressive regimen. Postoperative follow-up extends for at least three months, with serial clinical evaluations, renal function tests, Doppler ultrasound, and radiologic imaging when indicated to detect vascular complications and characterize graft function trajectories over time. The primary goal is to determine whether one suturing pattern is associated with more favorable ischemia metrics and hemodynamic parameters, thereby informing best practice for vascular anastomosis in living donor kidney transplantation.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients undergoing living donor kidney transplantation at Assiut Kidney Transplantation Unit since November 2015
Exclusion Criteria:
- Patients undergoing end-to-end arterial suturing with internal iliac artery
- Patients with acute allograft rejection within the first post-transplant week
- Patients with follow-up shorter than 3 months after transplantation
- Patients with missing relevant preoperative or postoperative data
- Patients refusing participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Interrupted Arterial Suturing
Adult living donor kidney transplant recipients whose renal artery is anastomosed end-to-side to the external or common iliac artery using interrupted 6/0 Prolene sutures as part of standard surgical practice.
|
|
Continuous Arterial Suturing
Adult living donor kidney transplant recipients whose renal artery is anastomosed end-to-side to the external or common iliac artery using continuous 6/0 Prolene sutures as part of standard surgical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cold Ischemia Time
Time Frame: From donor graft perfusion to arterial de-clamping during the transplant operation (single intraoperative measurement).
|
Duration in minutes from the start of graft perfusion with cold preservation solution in the donor to arterial de-clamping in the recipient, compared between interrupted and continuous arterial suturing groups.
|
From donor graft perfusion to arterial de-clamping during the transplant operation (single intraoperative measurement).
|
|
Early Graft Arterial Blood Flow (Resistive Index and Systolic Velocity)
Time Frame: Within the first 3 months after transplantation (assessments at approximately 1 week, 1 month, and 3 months post-transplant).
|
Mean systolic blood flow velocity and resistive index of the transplanted kidney artery measured by Doppler ultrasound and compared between interrupted and continuous arterial suturing groups.
|
Within the first 3 months after transplantation (assessments at approximately 1 week, 1 month, and 3 months post-transplant).
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- Arterial suturing in kidney
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