NCT02082613

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
2 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

March 6, 2014

Last Update Submit

April 6, 2016

Conditions

Testicular Hydrocele

Keywords

Testicular hydroceleHydroceleSclerotherapySurgeryComplications

Outcome Measures

Primary Outcomes (1)

  • Cure from symptomatic hydrocele within 6 months of randomization

    Every 3 months until 6months from randomization

Secondary Outcomes (1)

  • Postoperative complications

    Within 30 days from treatment

Other Outcomes (6)

  • Proportion symptomatic scrotal complaints without recurrence of hydrocele

    6 months

  • Proportion treatment failure

    6 months

  • Mean number of treatments until cure

    6 months

  • +3 more other outcomes

Study Arms (2)

Lord´s procedure

EXPERIMENTAL

Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions

Procedure: Lord´s procedure

Sclerotherapy

ACTIVE COMPARATOR

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

Interventions

Lord´s procedurePROCEDURE
Lord´s procedure
SclerotherapyPROCEDURE
Also known as: Polidocanol 30mg/ml, 4ml, Aetoxysclerol™ 30mg/ml, 4ml, Lauromakrogol 400 30mg/ml, 4ml
Sclerotherapy

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Drammen Hospital

Drammen, 3004, Norway

RECRUITING

Falu lasarett

Falun, Dalarna County, Sweden

RECRUITING

Östersunds hospital

Östersund, Jämtland County, 83183, Sweden

RECRUITING

Helsingborgs sjukhus

Helsingborg, Skåne County, Sweden

RECRUITING

Sundsvalls hospital

Sundsvall, Västernorrland County, Sweden

RECRUITING

Sunderby Hospital

Luleå, 97180, Sweden

RECRUITING

Umea University Hospital

Umeå, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Testicular Hydrocele

Interventions

SclerotherapyPolidocanol

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsPolyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Pär Nordin, Ph.D, MD

    Umeå University

    STUDY DIRECTOR

  • Karl-Johan Lundström, M.D

    Östersunds Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl-Johan Lundström, M.D

CONTACT

004663153000karl-johan.lundstrom@jll.se

Pär Nordin, Ph.D, M.D

CONTACT

004663153000par.nordin@jll.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, resident Urologist

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 10, 2014

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

NO(1)SE(6)