Scrotal Surgery After Laparoscopic Donor Nephrectomy: a Population-based Matched Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,878
- 试验地点
- 1
- 主要终点
- Scrotal Surgery
研究概览
简要总结
This study will examine whether laparoscopic nephrectomy is associated with a higher long-term risk of receiving scrotal surgery in male living kidney donors compared to male nondonors from the general population who have similar baseline health indicators. Both groups will be followed for many years.
详细描述
* Summary *
Background: It is underappreciated that some men who donate a kidney later experience unilateral scrotal pain and swelling on the same side of their nephrectomy. The condition can be assessed with an ultrasound, and some men undergo surgery for severe discomfort.
Methods: Using large provincial healthcare databases, the investigators will conduct a retrospective cohort study of approximately 800 male kidney donors who will be matched in a 1:10 ratio with 8000 male nondonors of similar baseline health from the general population. Laparoscopic nephrectomies will have occurred between 2002 and 2023 in the province of Ontario, Canada, with follow-up through linked healthcare databases until March 2024. Donors and nondonors will be matched for age, date of cohort entry, residency (urban or rural), income (average neighbourhood income categorized into fifths), a history of vasectomy, and a history of inguinal hernia repair. The primary outcome will be a hospital admission with receipt of surgery to address a unilateral scrotal fluid collection, typically involving hydrocele excision. The secondary outcome will be receipt of a scrotal ultrasound.
Study outcome: The study will determine if laparoscopic nephrectomy is associated with a higher long-term risk of receiving scrotal surgery or a scrotal ultrasound in male living kidney donors compared to male nondonors with similar indicators of baseline health.
* Literature Review *
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
- 是
入选标准
- •* Donors *
- •Inclusion criteria:
- •- Male persons who received a laparoscopic nephrectomy in Ontario, Canada between April 1, 2002, and March 31, 2023 are eligible to enter the study.
排除标准
- •Any person with data errors in their database records (such as missing or invalid age; they expect to exclude very few persons for these reasons). Data errors also include evidence of prior dialysis or a prior solid organ transplant, as such persons are not eligible to become a donor.
- •Any person who was not a permanent Ontario resident (i.e., they live outside of Ontario, and only came to Ontario to donate a kidney to their intended recipient). This will include anyone who is not eligible for the Ontario Health Insurance Plan, anyone whose date of last contact in the databases is less than 4 months after the cohort entry date, and any person without a physician visit in the last 1-year.
- •Any person who is <18 years of age on the date of nephrectomy (as only under exceptional circumstances should a person less than 18 be approved for living donation).
- •Any person who, before donation, received a scrotal ultrasound or a scrotal procedure other than a vasectomy.
- •Non-donors *
- •Inclusion, exclusion and selection criteria:
- •Before nephrectomy, living donors undergo rigorous health screening. The investigators will select a similarly healthy segment of the general population using restriction and matching.
- •The investigators will randomly assign a cohort-entry date (simulated nephrectomy date) to all male persons who were citizens in Ontario, according to the distribution of cohort-entry dates among donors (April 1, 2002, to March 31, 2023).
- •Excluded is any person with data errors in their database records (such as missing or invalid age); any person who was not a permanent Ontario resident. This will include anyone who is not eligible for the Ontario Health Insurance Plan, and anyone whose date of last contact in the databases is less than 4 months after the cohort entry date; any person who is <18 years of age on the cohort entry date
- •The investigators will then identify baseline illnesses and measures of healthcare access from historic records preceding the cohort entry date. They will then restrict the sample of eligible nondonors to persons without a recorded medical condition that could preclude donation. Such recorded medical conditions will include a hospitalization for mental illness in the prior year; an intensive care unit admission in the prior year; a hospitalization for palliative care services in the prior year; multiple hospital admissions in the prior year; high comorbidity (as assessed by the Charlson comorbidity index and adjusted clinical group scores); receipt of home oxygen therapy; residence at a long-term care facility; dementia; any record of prior nephrology consultation or kidney disease (including receipt of dialysis, a kidney biopsy, or a kidney procedure such as a partial or complete nephrectomy); previous solid organ transplant; disorders of the kidneys, ureters, or bladder; any record of cardiovascular disease (congestive heart failure, cardiovascular procedures, myocardial infarction, peripheral vascular disease, abdominal aortic aneurysm repair, ischemic stroke); hypertension in individuals <50 years of age (persons with this condition are not accepted as donors in Ontario); any record of obstructive sleep apnea; any cancer diagnosis; any liver disease or cirrhosis; diabetes; any serious infection (hepatitis, HIV, infective endocarditis); any record of autoimmune rheumatic conditions (such as rheumatoid arthritis or systemic lupus erythematosus); and any record of alcoholism.
- •The investigators will then exclude any person who, before cohort entry, received a scrotal ultrasound or a scrotal procedure other than a vasectomy.
- •To ensure the nondonors have the same opportunity as donors to obtain health care services from physicians, they will exclude nondonors who had no evidence of a family physician visit in the 2 years prior to index. They will also exclude nondonors with more than 4 family physician visits in the 2 years prior to index, as this could suggest they have an active health issue that needs attention before they would proceed to donate.
- •Matching *
- •The investigators will then match each donor to 10 eligible nondonors based on baseline characteristics that might be associated with the risk of scrotal surgery, specifically the age at the time of cohort entry (± 1 years), since amongst adults, as men age they are more likely to have hydroceles; the cohort entry date (± 3 years), to account for any era effects; urban or rural residence (population ≥ 10,000 or < 10,000), as a rural residence is associated with less access to care and worse outcomes; income (categorized into fifths of average neighborhood income), since lower income is associated with less access to care and worse outcomes; a prior history of vasectomy, and a prior history of inguinal hernia repair, as each procedure on occasion leads to chronic testicular pain. Each nondonor can only be selected once.
研究组 & 干预措施
male kidney donors
Male kidney donors who had a laparoscopic nephrectomy between April 1, 2002 and March 31, 2023 at transplant centres in the province of Ontario, Canada. Each donor's nephrectomy date will serve as their cohort entry date.
干预措施: Nephrectomy (Procedure)
male healthy nondonors
Before nephrectomy, living donors undergo rigorous health screening. A similarly healthy segment of the general population will be selected using restriction and matching. The investigators will randomly assign a cohort-entry date (simulated nephrectomy date) to all male citizens in Ontario, according to the distribution of cohort-entry dates among donors (between April 1, 2002 and March 31, 2023).
The investigators will identify baseline illnesses and measures of healthcare access using baseline records available before the cohort entry date. They will then restrict the sample to eligible nondonors without a recorded medical condition that could preclude donation. These restrictions will leave only a portion of citizens from the original sample as eligible nondonors.
The investigators will then match 10 eligible nondonors to each donor based on baseline characteristics that might be associated with the risk of scrotal surgery. Each nondonor can only be selected once.
结局指标
主要结局
Scrotal Surgery
时间窗: Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2023, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2024).
Hospital admission and receipt of surgery for a unilateral scrotal fluid collection such as 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.
次要结局
- Scrotal Ultrasound(Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2023, and will be followed until until study outcome, death, emigration from the province, or the end of the observation period (March 31, 2024).)