Risk of Scrotal Hydroceles After Nephrectomy For Kidney Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40,000
- 主要终点
- Hydrocelectomy
研究概览
简要总结
This population-based study will use provincial health administrative data to examine the risk of hospital admission for hydrocelectomy among males who underwent nephrectomy for kidney cancer, compared with males from the general population with similar baseline health characteristics, who did not undergo nephrectomy. We will use health administrative data from Ontario, Canada, to identify males who underwent nephrectomy for kidney cancer between 2002 and 2024. Four surgical cohorts will be constructed based on procedure type and surgical approach: laparoscopic total nephrectomy, open total nephrectomy, laparoscopic partial nephrectomy, and open partial nephrectomy. A propensity score will be calculated based on sociodemographic characteristics, comorbidities, and health care utilization. For each surgical cohort, patients will be matched to non-nephrectomy male controls (1:4) based on propensity score, age, index date, and modified Charlson Score (excluding cancer). The primary analysis will compare patients undergoing laparoscopic total nephrectomy and laparoscopic partial nephrectomy with matched non-nephrectomy controls from the general population. The primary outcome is hospital admission for hydrocelectomy. Secondary outcomes include diagnosis of hydrocele with receipt of a scrotal ultrasound, and receipt of a scrotal ultrasound. Additional analyses will compare surgical approaches.
详细描述
*Background*
Previous reports among male living kidney donors have documented postoperative testicular pain and/or scrotal swelling on the side of nephrectomy. Many affected donors were subsequently diagnosed with hydroceles and required surgical intervention (hydrocelectomy). However, existing studies were generally small, had limited follow-up, and lacked appropriate comparison groups.
To address these limitations, a large population-based study of living kidney donors was conducted. Male donors who underwent laparoscopic donor nephrectomy had a substantially higher incidence of scrotal surgery than matched nondonors: 7.8% of donors (70/898) underwent scrotal surgery compared with 0.2% of nondonors (19/8,980), corresponding to 8.3 versus 0.2 events per 1,000 person-years. The hazard ratio was 38.8 (95% CI, 22.1-67.9; P < 0.001), and the 20-year cumulative incidence was 13.8% in donors versus 0.7% in nondonors.
In exploratory secondary analyses, additional surgical cohorts were examined to determine whether similar patterns were observed following other kidney or retroperitoneal procedures. Compared with the general nonsurgical population, patients undergoing nephrectomy for reasons other than donation also appeared to have higher rates of subsequent scrotal surgery. Among those undergoing partial nephrectomy, incidence rates were 1.1 events per 1,000 person-years after laparoscopic procedures and 0.8 events per 1,000 person-years after open procedures. Among those undergoing total nephrectomy, incidence rates were 2.9 and 1.5 events per 1,000 person-years following laparoscopic and open procedures, respectively.
Although these analyses were descriptive and unadjusted for confounding, the findings raise the possibility that aspects of nephrectomy surgery, particularly laparoscopic approaches, may contribute to hydrocele formation. The reasons for this potential difference between laparoscopic and open approaches remain unclear. One proposed mechanism is disruption of lymphatic drainage or venous outflow along the gonadal vessels during retroperitoneal surgery. Because nephrectomy involves mobilization of the kidney and surrounding structures, it may affect scrotal lymphatic or venous drainage. However, the long-term risk of hydrocele formation and repair after nephrectomy performed for kidney cancer has not been well characterized.
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
- 0 Years 至 105 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •*Laparoscopic total nephrectomy*
- •Inclusion criteria
- •Male individuals who underwent laparoscopic complete/total nephrectomy between April 1, 2002, and March 31, 2024, with a most responsible diagnosis of malignant kidney, renal pelvis, or ureter cancer at the time of nephrectomy. The index date is defined as the date of the first laparoscopic total nephrectomy during the study period.
排除标准
- •Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 0 years of age or greater than 105 years of age, with a death record on or before their cohort entry, or have a date of last contact <4 months after cohort entry (to restrict to permanent residents of the province).
- •Prior partial nephrectomy at any time in the lookback.
- •Prior total nephrectomy before the start of accrual.
- •Individuals who underwent conversion from laparoscopic to open nephrectomy during the same surgical episode.
- •Individuals with no recorded primary care visit in the year prior to the index date.
- •History of scrotal or male genital conditions or procedures prior to the index date, including hydrocele, hydrocelectomy, scrotal ultrasound, scrotal or testicular malignancy, or other scrotal/genital procedures.
- •*Laparoscopic partial nephrectomy*
- •Inclusion criteria
- •Male individuals who underwent laparoscopic partial nephrectomy between April 1, 2002, and March 31, 2024, with a most responsible diagnosis of malignant kidney, renal pelvis, or ureter cancer at the time of nephrectomy. The index date is defined as the date of the first laparoscopic partial nephrectomy during the study period.
- •Exclusion criteria
- •Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 0 years of age or greater than 105 years of age, with a death record on or before their cohort entry, or have a date of last contact <4 months after cohort entry (to restrict to permanent residents of the province).
- •Prior total nephrectomy at any time in the lookback.
- •Any nephrectomy before the start of accrual.
- •Individuals who underwent conversion from laparoscopic to open nephrectomy during the same surgical episode.
- •Individuals with no recorded primary care visit in the year prior to the index date.
- •History of scrotal or male genital conditions or procedures prior to the index date, including hydrocele, hydrocelectomy, scrotal ultrasound, scrotal or testicular malignancy, or other scrotal/genital procedures.
- •*Open total nephrectomy*
- •Inclusion criteria
- •Male individuals who underwent open complete/total nephrectomy between April 1, 2002, and March 31, 2024, with a most responsible diagnosis of malignant kidney, renal pelvis, or ureter cancer at the time of nephrectomy. The index date is defined as the date of the first open total nephrectomy during the study period.
- •Exclusion criteria
- •Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 0 years of age or greater than 105 years of age, with a death record on or before their cohort entry, or have a date of last contact <4 months after cohort entry (to restrict to permanent residents of the province).
- •Prior partial nephrectomy at any time in the lookback.
- •Prior total nephrectomy before the start of accrual.
- •Individuals who underwent conversion from laparoscopic to open nephrectomy during the same surgical episode.
- •Individuals with no recorded primary care visit in the year prior to the index date.
- •History of scrotal or male genital conditions or procedures prior to the index date, including hydrocele, hydrocelectomy, scrotal ultrasound, scrotal or testicular malignancy, or other scrotal/genital procedures.
- •*Open partial nephrectomy*
- •Inclusion criteria
- •Male individuals who underwent open partial nephrectomy between April 1, 2002, and March 31, 2024, with a most responsible diagnosis of malignant kidney, renal pelvis, or ureter cancer at the time of nephrectomy. The index date is defined as the date of the first open partial nephrectomy during the study period.
- •Exclusion criteria
- •Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 0 years of age or greater than 105 years of age, with a death record on or before their cohort entry, or have a date of last contact <4 months after cohort entry (to restrict to permanent residents of the province).
- •Prior total nephrectomy at any time in the lookback.
- •Any nephrectomy before the start of accrual.
- •Individuals who underwent conversion from laparoscopic to open nephrectomy during the same surgical episode.
- •Individuals with no recorded primary care visit in the year prior to the index date.
- •History of scrotal or male genital conditions or procedures prior to the index date, including hydrocele, hydrocelectomy, scrotal ultrasound, scrotal or testicular malignancy, or other scrotal/genital procedures.
- •*Non-Nephrectomy Control Cohort*
- •Inclusion criteria
- •The control cohort will consist of male individuals identified in RPDB. Index dates will be randomly assigned by bootstrapping dates from the appropriate nephrectomy group, such that each control is assigned an actual nephrectomy index date randomly sampled with replacement from that group. Controls will be carefully screened to ensure that none are included in the nephrectomy cohort being compared.
- •Exclusion criteria
- •Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 0 years of age or greater than 105 years of age, with a death record on or before their cohort entry, or have a date of last contact <4 months after cohort entry (to restrict to permanent residents of the province).
- •Any nephrectomy (partial or total).
- •Individuals with no recorded primary care visit in the year prior to the index date.
- •History of scrotal or male genital conditions or procedures prior to the index date, including hydrocele, hydrocelectomy, scrotal ultrasound, scrotal or testicular malignancy, or other scrotal/genital procedures.
研究组 & 干预措施
Open partial nephrectomy
Males who underwent open partial nephrectomy for kidney cancer between April 1, 2002, and March 31, 2024. Surgeon-fee-for-service code (OHIP fee code: S411, S423) and a hospital-based procedural code (CCI: 1PC87LA, 1PC87LAXXE, 1PC87LAXXG, 1PC87NQ).
干预措施: Open nephrectomy for kidney cancer (Procedure)
Non-nephrectomy controls
Males from the general Ontario population who did not undergo any nephrectomy.
Laparoscopic total nephrectomy
Males who underwent laparoscopic total nephrectomy for kidney cancer between April 1, 2002, and March 31, 2024. Surgeon-fee-for-service code (OHIP fee code: E792, S413, S416, with no evidence of E766, E767, E768, S424, S420) and a hospital-based procedural code (CCI: 1PC89DA, 1PC91DA).
干预措施: Laparoscopic nephrectomy for kidney cancer (Procedure)
Laparoscopic partial nephrectomy
Males who underwent laparoscopic partial nephrectomy for kidney cancer between April 1, 2002, and March 31, 2024. Surgeon-fee-for-service code (OHIP fee code: S411, S423) and a hospital-based procedural code (CCI: 1PC87DA).
干预措施: Laparoscopic nephrectomy for kidney cancer (Procedure)
Open total nephrectomy
Males who underwent open total nephrectomy for kidney cancer between April 1, 2002, and March 31, 2024. Surgeon-fee-for-service code (OHIP fee code: S413, S415, S416, with no evidence of E792, E766, E767, E768, S424, S420) and a hospital-based procedural code (CCI: 1PC89LB, ; CCP: 674, 6741, 6742, 6744).
干预措施: Open nephrectomy for kidney cancer (Procedure)
结局指标
主要结局
Hydrocelectomy
时间窗: Follow-up period (index date to outcome, emigration, or maximum follow-up date [March 31, 2025]).
A hospital-based procedural code (CCI code: 1QH87LA, 1QH87LB, 1QH52HA, 1QH52LA, 1QH80LA, 1QG52HA, 1QG52LA; CCP code: 731, 730, 7391, 7339) and a surgeon-fee-for-service code (OHIP fee code: S611, S630) within 30 days.
次要结局
- Hydrocele diagnosis(Follow-up period (index date to outcome, emigration, or maximum follow-up date [March 31, 2025]).)
- Scrotal ultrasound(Follow-up period (index date to outcome, emigration, or maximum follow-up date [March 31, 2025]).)