Hydrocelectomies in Male Donors

NCT07078123 | Completed

• 1 other identifier: REB25-0054
• Study Type: observational
• Target: 2,750
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a population-based matched cohort study to examine whether male living kidney donors are at increased risk of undergoing hydrocelectomy compared to similar males in the general population. Using linked health administrative data from Alberta, Canada, male donors who underwent laparoscopic nephrectomy between 2002 and 2020 will be matched 1:10 to non-donors based on key demographic and clinical characteristics. Males will be followed for several years, from the time of cohort entry through the datasets until March 2021. The primary outcome is a hospital admission for hydrocelectomy in the follow-up period. The secondary outcome is receipt of a scrotal ultrasound.

Conditions

Hydrocele; Hydrocele of Tunica Vaginalis; Hydrocelectomy; Living Kidney Donor; Living Kidney Donation; Laparoscopic Nephrectomy

Keywords

hydrocele; living kidney donor; hydrocelectomy; laparoscopic nephrectomy

Outcome Measures

Primary Outcomes (1)

• Hydrocelectomy

  Hospital admission and receipt of surgery for a 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. 1 AHCIP code and 1 CCI code within 30 days: CCI: 1QH87LA, 1QH87LB, 1QH52HA, 1QH52LA, 1QH80LA, 1QG52HA, 1QG52LA AHCIP: 73.0, 73.0A, 73.1, 73.1A, 73.1B, 73.9, 73.91, 75.0

  Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2020, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2021).

Secondary Outcomes (1)

• Scrotal Ultrasound

  Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2020, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2021).

Study Arms (2)

Male Living Kidney Donors

Male kidney donors who had a laparoscopic nephrectomy between April 1, 2002 and March 31, 2020, at transplant centres in the province of Alberta, Canada. Each donor's nephrectomy date will serve as their cohort entry date.

Procedure: Laparoscopic Donor Nephrectomy

Male Non-Donors

A similarly healthy segment of the general Alberta population selected using restriction and matching to emulate the health criteria required to be met for living kidney donation. We will randomly assign a cohort-entry date (simulated nephrectomy date) to all male residents in Alberta, according to the distribution of cohort-entry dates among donors (between April 1, 2002 and March 31, 2020).

Interventions

Laparoscopic Donor Nephrectomy PROCEDURE

Receipt of a laparoscopic nephrectomy for kidney donation

Male Living Kidney Donors

Eligibility Criteria

• Age: 18 Years - 106 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include all male Alberta residents who underwent living donor nephrectomy between April 1, 2002, and March 31, 2020. The date of donation nephrectomy will be the index date. The non-donor comparator group will be drawn from the general population of all adult males in Alberta. The non-donor index date will be randomly assigned to all males in Alberta based on the distribution of the donors' nephrectomy dates (2002-2020). Each donor will be matched to 10 non-donors.

Donors: We will include male individuals who underwent laparoscopic donor nephrectomy in Alberta, Canada, between April 1, 2002, and March 31, 2020. * Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 18 years of age or greater than 105 years of age, who have a death record on or before the date of nephrectomy, or have a date of last contact \<4 months after cohort entry (i.e., they don't live permanently in the province), will be excluded. * Those with evidence of prior dialysis or a previous solid organ transplant will be excluded. * Individuals who have no physician visits within the last year will be excluded. * Individuals who, prior to donation, underwent a scrotal ultrasound or a scrotal procedure, other than a vasectomy or inguinal hernia repair, will be excluded. * We will exclude those who had an open nephrectomy, focusing on those who underwent laparoscopic surgery. Non-donors: Before nephrectomy, living donors undergo rigorous health screening, thus. we will select a similarly healthy cohort of the general population using restriction and matching. We will randomly assign a cohort-entry date (simulated nephrectomy date) to all male persons who were citizens in Alberta, according to the distribution of cohort-entry dates among donors (April 1, 2002, to March 31, 2020). To emulate the health status of living donors, we will further restrict the sample to exclude individuals with medical conditions that would typically preclude donation. Using data prior and at the time of cohort entry we will exclude: * Individuals with data record errors (e.g., missing or invalid age, sex, or date of birth), who are less than 18 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) * Those with evidence of prior dialysis or a previous solid organ transplant. * Any hospitalization for mental illness, palliative care, or multiple admissions in the prior year and any admission to an intensive care unit in the prior year. * High comorbidity, based on the Charlson comorbidity index (≥3) in the last 5 years. * Any resident in a long-term care facility or diagnosed with dementia. * Any history of kidney disease (including nephrology consultation, kidney biopsy, acute kidney disease, chronic kidney disease, or any disorders of the kidneys, ureters or bladder). * Any history of cardiovascular disease (including congestive heart failure, myocardial infarction, peripheral vascular disease, ischemic stroke, abdominal aortic aneurysm repair, or hypertension in individuals under 50 years of age). * Any form of cancer in the last five years, any history of liver disease or cirrhosis, diabetes, or serious infections such as hepatitis, HIV, or infective endocarditis. * Any autoimmune rheumatic conditions (including rheumatoid arthritis and systemic lupus erythematosus). * Any documented history of alcoholism in the last 5 years. * More than four family physician visits in the past two years (which suggests they have active medical issues). * No family physician visits in the past two years (to ensure they have access to a primary care physician). * Individuals who, prior to their assigned cohort entry date, underwent a scrotal ultrasound or a scrotal procedure, other than a vasectomy or inguinal hernia repair. Matching Donors will be matched 1:10 to eligible non-donors based on baseline characteristics that may influence the risk of undergoing a hydrocelectomy. Matching criteria will include: * Age at cohort entry, as the risk of hydrocele increases with age in adult males. * Cohort entry year, to account for potential temporal or era effects. * Urban vs. rural residence (defined by population ≥10,000 vs. \<10,000), given that rural residence may be associated with reduced access to care and poorer health outcomes. * Neighbourhood income quintile, as individuals from lower-income areas may face barriers to healthcare access and experience worse outcomes. * History of vasectomy and history of inguinal hernia repair, as both procedures can sometimes result in chronic testicular pain, which may be related to later hydrocelectomy. Each non-donor will be matched to only one donor, without replacement.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Calgary: collaborator

MeSH Terms

Conditions

Testicular Hydrocele

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist, Professor or Medicine, Epidemiology and Biostatistics

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: April 1, 2002
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share