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

April 6, 2016 updated by: Karl-Johan Lundström, Umeå University

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

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Drammen, Norway, 3004
        • Recruiting
        • Drammen Hospital
        • Contact:
          • Sven Petter Haugvik, M.D
      • Lulea, Sweden, 97180
      • Umea, Sweden, 90185
    • Dalarna
      • Falun, Dalarna, Sweden
        • Recruiting
        • Falu Lasarett
        • Contact:
          • Carl Gustav Arvidsson, M.D
        • Contact:
          • Nils Edström, M.D
    • Jämtland
      • Östersund, Jämtland, Sweden, 83183
        • Recruiting
        • Östersunds hospital
        • Principal Investigator:
          • Karl-Johan Lundström, M.D
    • Skåne
      • Helsingborg, Skåne, Sweden
        • Recruiting
        • Helsingborgs sjukhus
        • Contact:
          • Andreas Forsvall, M.D
    • Västernorrland
      • Sundsvall, Västernorrland, Sweden
        • Recruiting
        • Sundsvalls hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Other Names:
  • Polidocanol 30mg/ml, 4ml
  • Aetoxysclerol™ 30mg/ml, 4ml
  • Lauromakrogol 400 30mg/ml, 4ml

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
Every 3 months until 6months from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications
Time Frame: Within 30 days from treatment
Within 30 days from treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion symptomatic scrotal complaints without recurrence of hydrocele
Time Frame: 6 months
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.
6 months
Mean number of treatments until cure
Time Frame: 6 months
6 months
Mean days on sick leave
Time Frame: 30 days
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.
2-3months
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).
First visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pär Nordin, Ph.D, MD, Umea University
  • Principal Investigator: Karl-Johan Lundström, M.D, Östersunds hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

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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