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Kidney surgery linked to scrotum swelling? large study investigates

NCT ID NCT07483463

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study looked at health records of 15,000 males in Ontario, Canada, to see if those who had laparoscopic pyeloplasty (a surgery to fix a blocked kidney) were more likely to later need surgery for a hydrocele (a fluid-filled sac in the scrotum). Researchers compared these patients to similar males who did not have the kidney surgery. The goal was to understand if the kidney procedure increases the risk of developing a hydrocele.

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Study facts

What this study's own registry entry says, in plain language.

Participants

15,000 people

The number who actually took part.

Started

Apr 2002

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 to 105 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\*Laparoscopic Pyeloplasty Cohort\* Inclusion Criteria: 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. 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 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\* Inclusion Criteria: 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. 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 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\* Inclusion Criteria: The open cohort will include male individuals who underwent an open 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. 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 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

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Conditions

The condition(s) this trial relates to.

hydrocele Testicular Hydrocele

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

More trials for these conditions

Other studies related to the condition(s) this trial covers.