Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study
NCT ID: NCT02082613
Last Updated: 2016-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2015-02-28
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lord´s procedure
Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions
Lord´s procedure
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.
Sclerotherapy
Interventions
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Lord´s procedure
Sclerotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
MALE
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Karl-Johan Lundström
MD, resident Urologist
Principal Investigators
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Pär Nordin, Ph.D, MD
Role: STUDY_DIRECTOR
Umeå University
Karl-Johan Lundström, M.D
Role: PRINCIPAL_INVESTIGATOR
Östersunds Hospital
Locations
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Drammen Hospital
Drammen, , Norway
Falu lasarett
Falun, Dalarna County, Sweden
Östersunds hospital
Östersund, Jämtland County, Sweden
Helsingborgs sjukhus
Helsingborg, Skåne County, Sweden
Sundsvalls hospital
Sundsvall, Västernorrland County, Sweden
Sunderby Hospital
Luleå, , Sweden
Umea University Hospital
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Sven Petter Haugvik, M.D
Role: primary
Carl Gustav Arvidsson, M.D
Role: primary
Nils Edström, M.D
Role: backup
Andreas Forsvall, M.D
Role: primary
Other Identifiers
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JLL-378961
Identifier Type: -
Identifier Source: org_study_id
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