Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study
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|ClinicalTrials.gov Identifier: NCT02082613|
Recruitment Status : Unknown
Verified April 2016 by Karl-Johan Lundström, Umeå University.
Recruitment status was: Recruiting
First Posted : March 10, 2014
Last Update Posted : April 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Testicular Hydrocele||Procedure: Lord´s procedure Procedure: Sclerotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: Lord´s procedure
Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions
Procedure: Lord´s procedure
Active Comparator: Sclerotherapy
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.
- Cure from symptomatic hydrocele within 6 months of randomization [ Time Frame: Every 3 months until 6months from randomization ]
- Postoperative complications [ Time Frame: Within 30 days from treatment ]
- Proportion symptomatic scrotal complaints without recurrence of hydrocele [ Time Frame: 6 months ]
- Proportion treatment failure [ Time Frame: 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.
- Mean number of treatments until cure [ Time Frame: 6 months ]
- Mean days on sick leave [ Time Frame: 30 days ]
- Proportion cured by solely emptying the hydrocele [ Time Frame: 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.
- Description of inconvenience grade of patients with hydrocele [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082613
|Contact: Karl-Johan Lundström, M.Dfirstname.lastname@example.org|
|Contact: Pär Nordin, Ph.D, M.Demail@example.com|
|Drammen, Norway, 3004|
|Contact: Sven Petter Haugvik, M.D|
|Falun, Dalarna, Sweden|
|Contact: Carl Gustav Arvidsson, M.D|
|Contact: Nils Edström, M.D|
|Östersund, Jämtland, Sweden, 83183|
|Principal Investigator: Karl-Johan Lundström, M.D|
|Helsingborg, Skåne, Sweden|
|Contact: Andreas Forsvall, M.D|
|Sundsvall, Västernorrland, Sweden|
|Contact: Johan Styrke, MD 0046-70-2992048 firstname.lastname@example.org|
|Lulea, Sweden, 97180|
|Contact: Ioannis Beis, MD email@example.com|
|Umea University Hospital||Recruiting|
|Umea, Sweden, 90185|
|Contact: Jon Fridriksson, MD firstname.lastname@example.org|
|Study Director:||Pär Nordin, Ph.D, MD||Umeå University|
|Principal Investigator:||Karl-Johan Lundström, M.D||Östersunds hospital|