Clinical trial · Observational
Risk of Scrotal Hydroceles After Nephrectomy For Kidney Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hydrocele | — | UNRESOLVED | — |
| Hydrocelectomy | — | UNRESOLVED | — |
| Hydrocele of Tunica Vaginalis | — | UNRESOLVED | — |
| Kidney Cancers | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Laparoscopic Nephrectomy | — | UNRESOLVED | — |
| Nephrectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic nephrectomy for kidney cancer | Procedure | — | UNRESOLVED |
| Open nephrectomy for kidney cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Laparoscopic total nephrectomy
- description
- 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).
- interventionNames
- Procedure: Laparoscopic nephrectomy for kidney cancer
- label
- Laparoscopic partial nephrectomy
- description
- 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).
- interventionNames
- Procedure: Laparoscopic nephrectomy for kidney cancer
- label
- Open total nephrectomy
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 0 Years
- Maximum age
- 105 Years
Show eligibility criteria text
\*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. 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. \*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.
References
Publications (13)
- BACKGROUNDGarg AX, McArthur E, Sontrop JM, Boudville N, Connaughton DM, Cuerden MS, Feldman LS, Lam NN, Lentine KL, Nguan C, Parikh CR, Segev DL, Sener A, Smith G, Wang C, Weir MA, Yohanna S, Young A, Naylor KL. Risk for Scrotal Surgery After Laparoscopic Donor Nephrectomy : A Population-Based Cohort Study. Ann Intern Med. 2026 Jan;179(1):23-31. doi: 10.7326/ANNALS-25-02257. Epub 2025 Nov 11. PMID 41213151
- BACKGROUNDGjertson CK, Sundaram CP. Testicular pain following laparoscopic renal surgery. J Urol. 2008 Nov;180(5):2037-40; discussion 2040-1. doi: 10.1016/j.juro.2008.07.045. Epub 2008 Sep 18. PMID 18804234
- BACKGROUNDChoi SW, Moon HW, Kim KS, Choi YS, Cho HJ. Testicular Pain Following Laparoscopic Donor Nephrectomy: An Underreported Complication. J Endourol. 2024 Dec;38(12):1340-1345. doi: 10.1089/end.2024.0454. Epub 2024 Sep 16. PMID 39212680
- BACKGROUNDGarg AX, Feldman LS, Sontrop JM, Cuerden MS, Arnold JB, Boudville N, Karpinski M, Klarenbach S, Knoll G, Lok CE, McArthur E, Miller M, Monroy-Cuadros M, Naylor KL, Prasad GVR, Storsley L, Nguan C. Testicular Pain After Living Kidney Donation: Results From a Multicenter Cohort Study. Can J Kidney Health Dis. 2025 Mar 29;12:20543581251324610. doi: 10.1177/20543581251324610. eCollection 2025. PMID 40161413
- BACKGROUNDShirodkar SP, Gorin MA, Sageshima J, Bird VG, Martinez JM, Zarak A, Guerra G, Chen L, Burke GW, Ciancio G. Technical modification for laparoscopic donor nephrectomy to minimize testicular pain: a complication with significant morbidity. Am J Transplant. 2011 May;11(5):1031-4. doi: 10.1111/j.1600-6143.2011.03495.x. PMID 21521470
- BACKGROUNDSureka SK, Srivastava A, Agarwal S, Srivastava A, An S, Singh S, Mittal V, Patidar N, Kapoor R, Ansari MS. Prevention of Orchialgia After Left-Sided Laparoscopic Donor Nephrectomy-A Prospective Study. J Endourol. 2015 Jun;29(6):696-9. doi: 10.1089/end.2014.0645. Epub 2015 Jan 28.