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Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Karl-Johan Lundström, Umeå University

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.

Condition or disease Intervention/treatment Phase
Testicular Hydrocele Procedure: Lord´s procedure Procedure: Sclerotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Polidocanol

Arm Intervention/treatment
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.
Procedure: Sclerotherapy
Other Names:
  • Polidocanol 30mg/ml, 4ml
  • Aetoxysclerol™ 30mg/ml, 4ml
  • Lauromakrogol 400 30mg/ml, 4ml




Primary Outcome Measures :
  1. Cure from symptomatic hydrocele within 6 months of randomization [ Time Frame: Every 3 months until 6months from randomization ]

Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: Within 30 days from treatment ]

Other Outcome Measures:
  1. Proportion symptomatic scrotal complaints without recurrence of hydrocele [ Time Frame: 6 months ]
  2. 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.

  3. Mean number of treatments until cure [ Time Frame: 6 months ]
  4. Mean days on sick leave [ Time Frame: 30 days ]
  5. 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.

  6. 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).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Karl-Johan Lundström, M.D 004663153000 karl-johan.lundstrom@jll.se
Contact: Pär Nordin, Ph.D, M.D 004663153000 par.nordin@jll.se

Locations
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Norway
Drammen Hospital Recruiting
Drammen, Norway, 3004
Contact: Sven Petter Haugvik, M.D         
Sweden
Falu lasarett Recruiting
Falun, Dalarna, Sweden
Contact: Carl Gustav Arvidsson, M.D         
Contact: Nils Edström, M.D         
Östersunds hospital Recruiting
Östersund, Jämtland, Sweden, 83183
Principal Investigator: Karl-Johan Lundström, M.D         
Helsingborgs sjukhus Recruiting
Helsingborg, Skåne, Sweden
Contact: Andreas Forsvall, M.D         
Sundsvalls hospital Recruiting
Sundsvall, Västernorrland, Sweden
Contact: Johan Styrke, MD    0046-70-2992048    johan.styrke@umu.se   
Sunderby Hospital Recruiting
Lulea, Sweden, 97180
Contact: Ioannis Beis, MD       ioannis.beis@nll.se   
Umea University Hospital Recruiting
Umea, Sweden, 90185
Contact: Jon Fridriksson, MD       jon.fridriksson@umu.se   
Sponsors and Collaborators
Umeå University
Investigators
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Study Director: Pär Nordin, Ph.D, MD Umeå University
Principal Investigator: Karl-Johan Lundström, M.D Östersunds hospital

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Responsible Party: Karl-Johan Lundström, MD, resident Urologist, Umeå University
ClinicalTrials.gov Identifier: NCT02082613    
Other Study ID Numbers: JLL-378961
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Keywords provided by Karl-Johan Lundström, Umeå University:
Testicular hydrocele
Hydrocele
Sclerotherapy
Surgery
Complications
Additional relevant MeSH terms:
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Testicular Hydrocele
Genital Diseases, Male
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions