Risk of Hydroceles Following Pyeloplasty

NCT07483463 | Completed

• 1 other identifier: 2026 0906 626 001
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

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 laparoscopic pyeloplasty, compared with males from the general population with similar baseline health characteristics. We will use health administrative data from Ontario, Canada, to identify males who had a laparoscopic pyeloplasty between 2002 and 2024. We will calculate a propensity score based on sociodemographic characteristics, comorbidities, and health care utilization. We will then match laparoscopic pyeloplasty males to non-pyeloplasty male controls (1:10) based on propensity score, age, and index date. The primary outcome is hospital admission for hydrocelectomy. The secondary outcomes are a hydrocele diagnosis and receipt of a scrotal ultrasound.

Conditions

Hydrocele; Hydrocelectomy; Pyeloplasty

Keywords

pyeloplasty; hydrocelectomy; hydrocele

Outcome Measures

Primary Outcomes (1)

• Hydrocelectomy

  A hospital-based procedural code (CCI code: 1QH87LA, 1QH87LB, 1QH52HA, 1QH52LA, 1QH80LA, 1QG52HA, 1QG52LA) 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 (3)

Laparoscopic pyeloplasty

Ontario males who underwent laparoscopic pyeloplasty between April 1, 2002, and March 31, 2024. Hospital procedure code (CCI code: 1PE80DA, 1PE80DAFH, 1PE80DAXXE, 1PE76DA) and a surgeon-fee-for-service code (OHIP fee code: S422) within 30 days.

Procedure: Pyeloplasty

Non-pyeloplasty controls

Males of the general Ontario population who did not undergo pyeloplasty surgery.

Open pyeloplasty

Include Ontario males who underwent open pyeloplasty between April 1, 2002 and March 31, 2024. Hospital procedure code (CCI code: 1PE80LA, 1PE80LAFH, 1PE80LAXXE, 1PE80LAXXF, 1PE80LAXXG, 1PE80PF, 1PE80PFFH, 1PE80PFXXE, 1PE80PFXXF, 1PE80PFXXG) and a surgeon-fee-for-service code (OHIP fee code: S422) within 30 days.

Procedure: Pyeloplasty

Interventions

Pyeloplasty PROCEDURE

Underwent a pyeloplasty procedure from April 1, 2002, and March 31, 2024

Laparoscopic pyeloplasty; Open pyeloplasty

Eligibility Criteria

• Age: 0 Years - 105 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The laparoscopic pyeloplasty cohort will include all male Ontario residents who underwent laparoscopic pyeloplasty between April 1, 2002, and March 31, 2024. The open pyeloplasty cohort will include all male Ontario residents who underwent open pyeloplasty between April 1, 2002, and March 31, 2024, with the date of surgery serving as the index date. The non-pyeloplasty comparator group will be drawn from the general population of male Ontario residents. Controls will be assigned a random index date based on the distribution of surgery dates in the laparoscopic and open pyeloplasty cohorts (2002-2024). Each patient in the laparoscopic and open pyeloplasty cohorts will be matched to up to four non-pyeloplasty controls.

You may qualify if:

• This cohort will include male individuals who underwent a laparoscopic pyeloplasty between April 1, 2002, and March 31, 2024. For patients who have undergone more than one pyeloplasty, only the first procedure will be considered.

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 are non-Ontario residents or are OHIP ineligible on the index date (to restrict to permanent residents of the province).
• Anyone who had laparoscopic surgery to open surgery for pyeloplasty in the same index
• Previous scrotal or genital conditions or procedures (includes cancers, hydroceles, scrotal ultrasounds, etc.)
• Long-term care resident
• Any evidence of chronic dialysis
• No physician visits in the year prior to cohort entry
• \*Non-Pyeloplasty Control Cohort\*
• The control cohort will consist of male individuals identified in the RPDB (the general Ontario population). Index dates will be randomly assigned by bootstrapping dates from the pyeloplasty group, such that each control is assigned an actual pyeloplasty index date randomly sampled with replacement from that group. Controls will be carefully screened to ensure that none are included in the pyeloplasty cohorts.
• 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 are non-Ontario residents or are OHIP ineligible on the index date (to restrict to permanent residents of the province).
• Any evidence of previous pyeloplasty surgeries
• Previous scrotal or genital conditions or procedures (includes cancers, hydroceles, scrotal ultrasounds, etc.)
• Long-term care resident
• Any evidence of chronic dialysis
• No physician visits in the year prior to cohort entry
• \*Open Pyeloplasty Cohort\*

Sponsors & Collaborators

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

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 BACKGROUND

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: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: April 1, 2002
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: June 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share