Clinical trial NCT02082613: Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study
Official title: Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Testicular Hydrocele
Keywords: Testicular hydrocele
Hydrocele
Sclerotherapy
Surgery
Complications
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cure from symptomatic hydrocele within 6 months of randomization
timeFrame: Every 3 months until 6months from randomization
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within 30 days from treatment
Other outcomes:
measure: Proportion symptomatic scrotal complaints without recurrence of hydrocele
timeFrame: 6 months
measure: Proportion treatment failure
timeFrame: 6 months
measure: Mean number of treatments until cure
timeFrame: 6 months
measure: Mean days on sick leave
timeFrame: 30 days
measure: Proportion cured by solely emptying the hydrocele
timeFrame: 2-3months
measure: Description of inconvenience grade of patients with hydrocele
timeFrame: First visit
Locations:
city: Drammen
country: Norway
facility: Drammen Hospital
city: Falun
country: Sweden
facility: Falu lasarett
state: Dalarna
city: Östersund
country: Sweden
facility: Östersunds hospital
state: Jämtland
city: Helsingborg
country: Sweden
facility: Helsingborgs sjukhus
state: Skåne
city: Sundsvall
country: Sweden
facility: Sundsvalls hospital
state: Västernorrland
city: Lulea
country: Sweden
facility: Sunderby Hospital
city: Umea
country: Sweden
facility: Umea University Hospital
Study officials:
affiliation: Umeå University
name: Pär Nordin, Ph.D, MD
role: STUDY_DIRECTOR
affiliation: Östersunds Hospital
name: Karl-Johan Lundström, M.D
role: PRINCIPAL_INVESTIGATOR
References: