NCT07527637

Brief Summary

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 1992 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1992

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1992

Completed
31.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

31.8 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

laparoscopicnephrectomyhydrocelehydrocelectomykidney cancer

Outcome Measures

Primary Outcomes (1)

  • Hydrocelectomy

    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.

    Follow-up period (index date to outcome, emigration, or maximum follow-up date [March 31, 2025]).

Secondary Outcomes (2)

  • 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]).

Study Arms (5)

Laparoscopic total nephrectomy

Males who underwent laparoscopic total nephrectomy for kidney cancer between July 1, 1992 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; CCP: 674, 6741, 6742, 6744).

Procedure: Laparoscopic nephrectomy for kidney cancer

Laparoscopic partial nephrectomy

Males who underwent laparoscopic partial nephrectomy for kidney cancer between July 1, 1992 and March 31, 2024. Surgeon-fee-for-service code (OHIP fee code: S411, S423) and a hospital-based procedural code (CCI: 1PC87DA; CCP: 673).

Procedure: Laparoscopic nephrectomy for kidney cancer

Open total nephrectomy

Males who underwent open total nephrectomy for kidney cancer between July 1, 1992 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, 1PC89PF, 1PC89QF, 1PC91LB, 1PC91PF, 1PC91QF; CCP: 674, 6741, 6742, 6744).

Procedure: Open nephrectomy for kidney cancer

Open partial nephrectomy

Males who underwent open partial nephrectomy for kidney cancer between July 1, 1992 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; CCP: 673).

Procedure: Open nephrectomy for kidney cancer

Non-nephrectomy controls

Males from the general Ontario population who did not undergo any nephrectomy.

Interventions

Receipt of a laparoscopic (total or partial) nephrectomy for kidney cancer

Laparoscopic partial nephrectomyLaparoscopic total nephrectomy

Receipt of an open (total or partial) nephrectomy for kidney cancer

Open partial nephrectomyOpen total nephrectomy

Eligibility Criteria

Age0 Years - 105 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male residents of Ontario, Canada identified through provincial administrative health databases who underwent nephrectomy for kidney cancer between July 1, 1992 and March 31, 2024, along with matched non-nephrectomy controls from the general population.

You may qualify if:

  • Male individuals who underwent laparoscopic complete/total nephrectomy between July 1, 1992, 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.

You may not qualify if:

  • 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 (before July 1, 1992).
  • 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\*
  • Male individuals who underwent laparoscopic partial nephrectomy between July 1, 1992 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.
  • 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 (before July 1, 1992).
  • 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\*
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Garg 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: 41213151BACKGROUND
  • Gjertson 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: 18804234BACKGROUND
  • Choi 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: 39212680BACKGROUND
  • Garg 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: 40161413BACKGROUND
  • Shirodkar 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: 21521470BACKGROUND
  • Sureka 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.

    PMID: 25401724BACKGROUND
  • El Hennawy HM, Al Faifi AS, Al Atta E, Safar O, Thamer S, El Nazer W, Kamal AI, Abdelaziz AA, Kawasmeh SA, Mirza N, Zaitoun MF, Al-Alsheikh K, Shalkamy O, Mahedy A. Post-Laparoendoscopic Single-Site Donor Nephrectomy Ipsilateral Testicular Pain, Does Operative Technique Matter? A Single Center Experience and Review of Literature. Minim Invasive Surg. 2022 Mar 23;2022:3292048. doi: 10.1155/2022/3292048. eCollection 2022.

    PMID: 35721390BACKGROUND
  • Pinar U, Pettenati C, Hurel S, Pietak M, Dariane C, Audenet F, Legendre C, Rozenberg A, Mejean A, Timsit MO. Persistent orchialgia after laparoscopic living-donor nephrectomy: an underestimated complication requiring information adjustment. World J Urol. 2021 Feb;39(2):621-627. doi: 10.1007/s00345-020-03228-6. Epub 2020 May 3.

    PMID: 32363451BACKGROUND
  • Schoephoerster J, Matas A, Jackson S, Pruett TL, Finger E, Kandaswamy R, Dunn T, Kirchner V, Anderson JK, Humphreville V. Orchialgia After Living Donor Nephrectomy: An Underreported Entity. Transplant Direct. 2022 Oct 24;8(11):e1383. doi: 10.1097/TXD.0000000000001383. eCollection 2022 Nov.

    PMID: 36299443BACKGROUND
  • Srivastava A, Kapoor R, Srivastava A, Ansari MS, Singh M, Kapoor R. Orchialgia after laproscopic renal surgery: a common problem with questionable etiology. Are there any predictors? World J Urol. 2013 Oct;31(5):1153-7. doi: 10.1007/s00345-012-0864-7. Epub 2012 Apr 15.

    PMID: 22527670BACKGROUND
  • Chin EH, Hazzan D, Herron DM, Gaetano JN, Ames SA, Bromberg JS, Edye M. Laparoscopic donor nephrectomy: intraoperative safety, immediate morbidity, and delayed complications with 500 cases. Surg Endosc. 2007 Apr;21(4):521-6. doi: 10.1007/s00464-006-9021-y. Epub 2006 Dec 16.

    PMID: 17180288BACKGROUND
  • Jalali M, Rahmani S, Joyce AD, Cartledge JJ, Lewis MH, Ahmad N. Laparoscopic donor nephrectomy: an increasingly common cause for testicular pain and swelling. Ann R Coll Surg Engl. 2012 Sep;94(6):407-10. doi: 10.1308/003588412X13171221592177.

    PMID: 22943330BACKGROUND
  • Kim FJ, Pinto P, Su LM, Jarrett TW, Rattner LE, Montgomery R, Kavoussi LR. Ipsilateral orchialgia after laparoscopic donor nephrectomy. J Endourol. 2003 Aug;17(6):405-9. doi: 10.1089/089277903767923209.

    PMID: 12965068BACKGROUND

MeSH Terms

Conditions

Testicular HydroceleKidney Neoplasms

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System DiseasesUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

July 1, 1992

Primary Completion

March 31, 2024

Study Completion

March 31, 2025

Last Updated

April 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The dataset from this study is held securely in coded form at ICES. While legal data sharing agreements between ICES and data providers (e.g., healthcare organizations and government) prohibit ICES from making the dataset publicly available, access may be granted to those who meet pre-specified criteria for confidential access, available at www.ices.on.ca/DAS (email: das@ices.on.ca). The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the computer programs may rely upon coding templates or macros that are unique to ICES and are therefore either inaccessible or may require modification.