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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lord´s procedure | Experimental | Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions |
|
| Sclerotherapy | Active Comparator | Sclerotherapy with 4 ml of polidocanol 30mg/ml after complete emptying of the hydrocele. With or without local anesthesia, not performed in an operation room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lord´s procedure | Procedure |
| ||
| Sclerotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Cure from symptomatic hydrocele within 6 months of randomization | Every 3 months until 6months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Within 30 days from treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion symptomatic scrotal complaints without recurrence of hydrocele | 6 months | |
| Proportion treatment failure | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl-Johan Lundström, M.D | Contact | 004663153000 | karl-johan.lundstrom@jll.se | |
| Pär Nordin, Ph.D, M.D | Contact | 004663153000 | par.nordin@jll.se |
| Name | Affiliation | Role |
|---|---|---|
| Pär Nordin, Ph.D, MD | Umeå University | Study Director |
| Karl-Johan Lundström, M.D | Östersunds Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drammen Hospital | Recruiting | Drammen | 3004 | Norway |
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| ID | Term |
|---|---|
| D006848 | Testicular Hydrocele |
| ID | Term |
|---|---|
| D013733 | Testicular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015911 | Sclerotherapy |
| D000077423 | Polidocanol |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
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|
|
| 6 months |
| Mean number of treatments until cure | 6 months |
| Mean days on sick leave | 30 days |
| Proportion cured by solely emptying the hydrocele | 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. | 2-3months |
| Description of inconvenience grade of patients with hydrocele | The inconvenience grade for patients presenting in a urological out patient setting, reported as a 7 scale question, (adopted from Inguinal Pain questionnaire). | First visit |
| Falu lasarett | Recruiting | Falun | Dalarna County | Sweden |
|
| Östersunds hospital | Recruiting | Östersund | Jämtland County | 83183 | Sweden |
|
| Helsingborgs sjukhus | Recruiting | Helsingborg | Skåne County | Sweden |
|
| Sundsvalls hospital | Recruiting | Sundsvall | Västernorrland County | Sweden |
|
| Sunderby Hospital | Recruiting | Luleå | 97180 | Sweden |
|
| Umea University Hospital | Recruiting | Umeå | 90185 | Sweden |
|
| D052801 |
| Male Urogenital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006018 |
| Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |