- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082613
Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study
Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karl-Johan Lundström, M.D
- Phone Number: 004663153000
- Email: karl-johan.lundstrom@jll.se
Study Contact Backup
- Name: Pär Nordin, Ph.D, M.D
- Phone Number: 004663153000
- Email: par.nordin@jll.se
Study Locations
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Drammen, Norway, 3004
- Recruiting
- Drammen Hospital
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Contact:
- Sven Petter Haugvik, M.D
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Lulea, Sweden, 97180
- Recruiting
- Sunderby Hospital
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Contact:
- Ioannis Beis, MD
- Email: ioannis.beis@nll.se
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Umea, Sweden, 90185
- Recruiting
- Umeå University Hospital
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Contact:
- Jon Fridriksson, MD
- Email: jon.fridriksson@umu.se
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Dalarna
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Falun, Dalarna, Sweden
- Recruiting
- Falu Lasarett
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Contact:
- Carl Gustav Arvidsson, M.D
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Contact:
- Nils Edström, M.D
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Jämtland
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Östersund, Jämtland, Sweden, 83183
- Recruiting
- Östersunds hospital
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Principal Investigator:
- Karl-Johan Lundström, M.D
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Skåne
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Helsingborg, Skåne, Sweden
- Recruiting
- Helsingborgs sjukhus
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Contact:
- Andreas Forsvall, M.D
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Västernorrland
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Sundsvall, Västernorrland, Sweden
- Recruiting
- Sundsvalls hospital
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Contact:
- Johan Styrke, MD
- Phone Number: 0046-70-2992048
- Email: johan.styrke@umu.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lord´s procedure
Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cure from symptomatic hydrocele within 6 months of randomization
Time Frame: Every 3 months until 6months from randomization
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Every 3 months until 6months from randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative complications
Time Frame: Within 30 days from treatment
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Within 30 days from treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion symptomatic scrotal complaints without recurrence of hydrocele
Time Frame: 6 months
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6 months
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Proportion treatment failure
Time Frame: 6 months
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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.
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6 months
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Mean number of treatments until cure
Time Frame: 6 months
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6 months
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Mean days on sick leave
Time Frame: 30 days
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30 days
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Proportion cured by solely emptying the hydrocele
Time Frame: 2-3months
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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.
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2-3months
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Description of inconvenience grade of patients with hydrocele
Time Frame: First visit
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The inconvenience grade for patients presenting in a urological out patient setting, reported as a 7 scale question, (adopted from Inguinal Pain questionnaire).
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First visit
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pär Nordin, Ph.D, MD, Umea University
- Principal Investigator: Karl-Johan Lundström, M.D, Östersunds hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JLL-378961
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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