Effects of Graft Vascular Dimensions on Surgical and Functional Outcomes of Living Donor Kidney Transplantation

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05797389
Collaborator
(none)
30
24

Study Details

Study Description

Brief Summary

  1. Correlate the radiological and intraoperative measuring of the vascular dimensions,

  2. Assess the effect of the vascular dimensions on the short-term surgical complications and

  3. Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Vascular complications after kidney transplantation (KT) are variably rare with an incidence of 3-15%. They are a significant and most serious part of surgical complications of KT. They may acutely result in graft loss during surgery or early in the perioperative period and may threaten patient's life. The most common forms of early vascular complications are haemorrhage, hematomas, arterial or venous thrombosis, arterial vasospasm, and arterial intimal dissection. In pediatric and adult KT, most studies addressing the vascular complications followed a common attitude of estimating the prevalence and management of these complications rather than studying the predisposing factors. Specifically, studying the normal and abnormal anatomy of the grafts has mainly been directed towards the number of graft vessels. However, there are many other vascular parameters that may potentially influence the outcome of vascular anastomosis and therefore the graft and patient outcomes. To the best of the investigators knowledge, the vascular dimensions of the renal and iliac vessels, such as the length, diameter and site of anastomosis to the iliac vessels have not been studied before so the investigators hypothesis that these dimensions can unequally affect the outcomes of surgery and early graft function in KTs. Hence, this study will be conducted to assess the effects of the vascular dimensions on the outcomes of surgery and primary graft function in pediatric versus adult living donor KT.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Effects of Graft Vascular Dimensions on Perioperative Surgical and Functional Outcomes of Living Donor Kidney Transplantation in Pediatrics and Adults: A Prospective Case Series
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Mode of graft function defined by: 1- the time of start of diuresis post-transplantation. [one month post operative.]

      Mode of graft function defined by: 1- the start of diuresis (sufficient amount of urine production) within one hour of declamping through the first week post-transplantation

    2. 2- Rate of decline of the serum creatinine level. [one month post operative.]

      2- Rate of decline of the serum creatinine level.

    Secondary Outcome Measures

    1. The rate of vascular complications (intra- or perioperative). [one month post operative]

      The rate of vascular complications (intra- or perioperative): In the form of spasm, hemorrhage, dissection, or thrombosis.

    2. The rate of other surgical complications. [one month post operative]

      The rate of other surgical complications.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pediatric and adult patients undergoing living donor kidney transplantation.
    Exclusion Criteria:
    • Patients with acute graft rejection occurring within the first week of transplantation.

    • Patients refusing participation in the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Loay, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05797389
    Other Study ID Numbers:
    • vascular dimensions and KT
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohamed Loay, Assistant lecturer, Assiut University

    Study Results

    No Results Posted as of Apr 4, 2023