Scrotal Surgery After Laparoscopic Donor Nephrectomy

NCT06716723 | Completed

• 2 other identifiers: 2025 0906 443 005148377
• Study Type: observational
• Target: 9,878
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether laparoscopic nephrectomy is associated with a higher long-term risk of receiving scrotal surgery in male living kidney donors compared to male nondonors from the general population who have similar baseline health indicators. Both groups will be followed for many years.

Conditions

Living Donor Nephrectomy

Keywords

living kidney donation; Scrotal surgery; cohort study; nephrectomy

Outcome Measures

Primary Outcomes (1)

• Scrotal Surgery

  Hospital admission and receipt of surgery for a unilateral scrotal fluid collection such as 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.

  Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2023, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2024).

Secondary Outcomes (1)

• Scrotal Ultrasound

  Donors and their matched non-donors will enter the cohort between April 1, 2002 and March 31, 2023, and will be followed until until study outcome, death, emigration from the province, or the end of the observation period (March 31, 2024).

Study Arms (2)

male kidney donors

Male kidney donors who had a laparoscopic nephrectomy between April 1, 2002 and March 31, 2023 at transplant centres in the province of Ontario, Canada. Each donor's nephrectomy date will serve as their cohort entry date.

Procedure: Nephrectomy

male healthy nondonors

Before nephrectomy, living donors undergo rigorous health screening. A similarly healthy segment of the general population will be selected using restriction and matching. The investigators will randomly assign a cohort-entry date (simulated nephrectomy date) to all male citizens in Ontario, according to the distribution of cohort-entry dates among donors (between April 1, 2002 and March 31, 2023). The investigators will identify baseline illnesses and measures of healthcare access using baseline records available before the cohort entry date. They will then restrict the sample to eligible nondonors without a recorded medical condition that could preclude donation. These restrictions will leave only a portion of citizens from the original sample as eligible nondonors. The investigators will then match 10 eligible nondonors to each donor based on baseline characteristics that might be associated with the risk of scrotal surgery. Each nondonor can only be selected once.

Interventions

Nephrectomy PROCEDURE

Receipt of a laparoscopic nephrectomy for kidney donation

male 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

Male kidney donors who underwent laparoscopic nephrectomy matched to male nondonors from the general population with similar indicators of baseline health.

You may qualify if:

• \- Male persons who received a laparoscopic nephrectomy in Ontario, Canada between April 1, 2002, and March 31, 2023 are eligible to enter the study.

You may not qualify if:

• Any person with data errors in their database records (such as missing or invalid age; they expect to exclude very few persons for these reasons). Data errors also include evidence of prior dialysis or a prior solid organ transplant, as such persons are not eligible to become a donor.
• Any person who was not a permanent Ontario resident (i.e., they live outside of Ontario, and only came to Ontario to donate a kidney to their intended recipient). This will include anyone who is not eligible for the Ontario Health Insurance Plan, anyone whose date of last contact in the databases is less than 4 months after the cohort entry date, and any person without a physician visit in the last 1-year.
• Any person who is \<18 years of age on the date of nephrectomy (as only under exceptional circumstances should a person less than 18 be approved for living donation).
• Any person who, before donation, received a scrotal ultrasound or a scrotal procedure other than a vasectomy.
• Non-donors \*
• Before nephrectomy, living donors undergo rigorous health screening. The investigators will select a similarly healthy segment of the general population using restriction and matching.
• The investigators will randomly assign a cohort-entry date (simulated nephrectomy date) to all male persons who were citizens in Ontario, according to the distribution of cohort-entry dates among donors (April 1, 2002, to March 31, 2023).
• Excluded is any person with data errors in their database records (such as missing or invalid age); any person who was not a permanent Ontario resident. This will include anyone who is not eligible for the Ontario Health Insurance Plan, and anyone whose date of last contact in the databases is less than 4 months after the cohort entry date; any person who is \<18 years of age on the cohort entry date
• The investigators will then identify baseline illnesses and measures of healthcare access from historic records preceding the cohort entry date. They will then restrict the sample of eligible nondonors to persons without a recorded medical condition that could preclude donation. Such recorded medical conditions will include a hospitalization for mental illness in the prior year; an intensive care unit admission in the prior year; a hospitalization for palliative care services in the prior year; multiple hospital admissions in the prior year; high comorbidity (as assessed by the Charlson comorbidity index and adjusted clinical group scores); receipt of home oxygen therapy; residence at a long-term care facility; dementia; any record of prior nephrology consultation or kidney disease (including receipt of dialysis, a kidney biopsy, or a kidney procedure such as a partial or complete nephrectomy); previous solid organ transplant; disorders of the kidneys, ureters, or bladder; any record of cardiovascular disease (congestive heart failure, cardiovascular procedures, myocardial infarction, peripheral vascular disease, abdominal aortic aneurysm repair, ischemic stroke); hypertension in individuals \<50 years of age (persons with this condition are not accepted as donors in Ontario); any record of obstructive sleep apnea; any cancer diagnosis; any liver disease or cirrhosis; diabetes; any serious infection (hepatitis, HIV, infective endocarditis); any record of autoimmune rheumatic conditions (such as rheumatoid arthritis or systemic lupus erythematosus); and any record of alcoholism.
• The investigators will then exclude any person who, before cohort entry, received a scrotal ultrasound or a scrotal procedure other than a vasectomy.
• To ensure the nondonors have the same opportunity as donors to obtain health care services from physicians, they will exclude nondonors who had no evidence of a family physician visit in the 2 years prior to index. They will also exclude nondonors with more than 4 family physician visits in the 2 years prior to index, as this could suggest they have an active health issue that needs attention before they would proceed to donate.
• Matching \*
• The investigators will then match each donor to 10 eligible nondonors based on baseline characteristics that might be associated with the risk of scrotal surgery, specifically the age at the time of cohort entry (± 1 years), since amongst adults, as men age they are more likely to have hydroceles; the cohort entry date (± 3 years), to account for any era effects; urban or rural residence (population ≥ 10,000 or \< 10,000), as a rural residence is associated with less access to care and worse outcomes; income (categorized into fifths of average neighborhood income), since lower income is associated with less access to care and worse outcomes; a prior history of vasectomy, and a prior history of inguinal hernia repair, as each procedure on occasion leads to chronic testicular pain. Each nondonor can only be selected once.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

ICES

London, Ontario, Canada

Location

Related Publications (1)

• 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: 41213151 DERIVED

MeSH Terms

Interventions

Nephrectomy

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: April 1, 2002
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 13, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)