Testicular Hydrocele Clinical Trial
Official title:
Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.
This study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. Thirty days complication rates will be assessed. The hypothesis is that surgery will lead to faster cure while sclerotherapy would be cheaper and have less complications.
Testicular hydrocele is a common disorder even though it´s exact prevalence is unknown. In
areas with filariasis it´s endemic.
Hydrocele is a benign condition where fluid accumulates in between two layers of tunica
vaginalis (embryologically, the peritoneum), surrounding the testicle. The cause is unknown
but inflammatory conditions is believed to induce these changes. The pathogenesis of
hydrocele is believed to be a nonbalanced secretion and resorption of fluid.
Diagnosis of hydrocele is easy since the patient presents with an enlarged scrotum and
clinical investigation including palpation and transillumination of the scrotum confirms the
diagnosis. A scrotal ultrasound might be indicated to rule out a malignancy or if the
diagnosis is unclear.
Treatment for hydrocele is only indicated when the patient has symptoms since all treatment
modalities carries risk of complications, such as hematoma, infection, pain and even
infertility concerns has been raised.
Operative management is considered the golden standard of treatment when considering
recurrence but less invasive procedures such as sclerotherapy is frequently used, mainly due
to cost and complications issues.
Lord´s procedure has in several series shown low frequency of complications and excellent
recurrence rates. However, Lord´s procedure and sclerotherapy has not been tested head to
head and the optimal treatment for hydrocele is yet to be determined.
This study aims to compare these techniques and evaluate the results within 1 year after
randomization on cure, complication rates and various secondary descriptive outcomes.
The investigators aim to adhere to CONSORT.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02304575 -
Quality of Life Among Testicular Cancer Survivors
|
N/A |