Testicular Hydrocele
Conditions
Keywords
Testicular hydrocele, Hydrocele, Sclerotherapy, Surgery, Complications
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELord´s procedure
PROCEDURESclerotherapy
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic testicular hydrocele, with more than 2 points on a validated inguinal botherscore (Inguinal Pain Questionnaire, IPQ) * More than 40ml of hydrocele fluid * Age\>40 years * Completed reproduction * Oral and written consent to participate in the study * American Association of Anesthesiology (ASA) grade≤ 3
Exclusion criteria
* Other ipsilateral scrotal disease (tumour, ongoing inflammatory disease of the scrotum,) * Ongoing urinary infection * Ipsilateral inguinal hernia * Ascites * Paternity wish * Not possible to drain the hydrocele fully * Opaque fluid drained on emptying the hydrocele * Bilateral hydrocele where both sides has symptom score more than 2p on IPQ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure from symptomatic hydrocele within 6 months of randomization | Every 3 months until 6months from randomization |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complications | Within 30 days from treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean number of treatments until cure | 6 months | — |
| Mean days on sick leave | 30 days | — |
| Proportion symptomatic scrotal complaints without recurrence of hydrocele | 6 months | — |
| Description of inconvenience grade of patients with hydrocele | First visit | The inconvenience grade for patients presenting in a urological out patient setting, reported as a 7 scale question, (adopted from Inguinal Pain questionnaire). |
| Proportion cured by solely emptying the hydrocele | 2-3months | Patients who are randomized to surgery will undergo an emptying of the hydrocele to allow for clinical examination of the testicle. The amount will be measured and inspected. No sclerotherapy will be instilled. If patients are cured by this simple measure, they will be classified as cured by this and analyzed as cured by surgery, in intention to treat analysis. |
| Proportion treatment failure | 6 months | The proportion of men who in this combined outcome showed either recurrence, significant symptoms but refuses further treatment, residual symptoms without hydrocele or patient preference to change treatment modality, converting from one treatment arm to the other. |
Countries
Norway, Sweden
Contacts
Primary ContactKarl-Johan Lundström, M.D
Backup ContactPär Nordin, Ph.D, M.D
Outcome results
None listed