NCT07527637Fut, nem toboroz
Risk of Scrotal Hydroceles After Nephrectomy For Kidney Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 14.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 40000 (tényleges)
- Első benyújtás
- 2026. ápr. 7.
- Kezdés
- 2002. ápr. 1.
- Elsődleges befejezés
- 2024. márc. 31.
- Fő szponzor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Betegségek
- Vesedaganat, Gyermekkori daganatok
- NCT-szám
- NCT07527637
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 40000
- 2002. ápr. 1. és az elsődleges befejezés (2024. márc. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- 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*
- Prior total nephrectomy at any time in the lookback.
- 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*
- 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*
- Prior total nephrectomy at any time in the lookback.
- 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*
- 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.
Életkor
- 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).
- 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).
- 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).
- 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).
- 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).
Egyéb
- Any nephrectomy before the start of accrual.
- Any nephrectomy before the start of accrual.
- Any nephrectomy (partial or total).
Kiket keres a vizsgálat
- 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.
- 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.
- 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.
- 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.
- 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.
A regiszterben nem jelölt feltételek
- *Laparoscopic total nephrectomy*
Életkor a regiszterben: 0 év – 105 év · Nem: csak férfiak · Egészséges önkénteseket is fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.