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临床试验/NCT07078123
NCT07078123已完成不适用

Risk of Hydrocelectomy After Laparoscopic Living Donor Nephrectomy

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's0 个研究点目标入组 2,750 人开始时间: 2002年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,750
主要终点
Hydrocelectomy

研究概览

简要总结

This is a population-based matched cohort study to examine whether male living kidney donors are at increased risk of undergoing hydrocelectomy compared to similar males in the general population. Using linked health administrative data from Alberta, Canada, male donors who underwent laparoscopic nephrectomy between 2002 and 2020 will be matched 1:10 to non-donors based on key demographic and clinical characteristics. Males will be followed for several years, from the time of cohort entry through the datasets until March 2021. The primary outcome is a hospital admission for hydrocelectomy in the follow-up period. The secondary outcome is receipt of a scrotal ultrasound.

详细描述

*Summary*

Background: Some male living kidney donors experience scrotal pain and swelling on the same side as their nephrectomy following donation, occasionally requiring surgical intervention for relief.

Methods: In a population-based cohort study, we will identify male living kidney donors who underwent laparoscopic nephrectomy in Alberta, Canada, between 2002 and 2020. Each donor will be matched 1:10 to male non-donors from the general Alberta population with similar baseline health characteristics. Matching variables will include age, cohort entry date, rural versus urban residence, income quintile, prior vasectomy, and history of inguinal hernia repair. Donors and non-donors will be followed using linked provincial healthcare administrative databases in Alberta, Canada, until March 31, 2021. The primary outcome will be hospital admission for hydrocelectomy. The secondary outcome will be the receipt of a scrotal ultrasound.

Study Objective: This study aims to determine whether male living kidney donors who undergo laparoscopic nephrectomy have a higher risk of hydrocelectomy compared to matched male non-donors with similar baseline health profiles.

*Background*

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 106 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hydrocelectomy

时间窗: Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2020, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2021).

Hospital admission and receipt of surgery for a hydrocele excision. To be confident in outcome ascertainment, evidence of both a surgeon-fee-for-service code and a hospital-based procedural code will be required, with each recorded in separate healthcare databases by different personnel. 1 AHCIP code and 1 CCI code within 30 days: CCI: 1QH87LA, 1QH87LB, 1QH52HA, 1QH52LA, 1QH80LA, 1QG52HA, 1QG52LA AHCIP: 73.0, 73.0A, 73.1, 73.1A, 73.1B, 73.9, 73.91, 75.0

次要结局

  • Scrotal Ultrasound(Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2020, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2021).)

研究者

发起方
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Garg

Nephrologist, Professor or Medicine, Epidemiology and Biostatistics

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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