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

Testicular Hydrocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02082613
• Other study ID #: JLL-378961
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2014
• Last updated: April 6, 2016
• Start date: February 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: Umeå University
• Contact: Karl-Johan Lundström, M.D
• Phone: 004663153000
• Email: karl-johan.lundstrom[@]jll.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Testicular Hydrocele

Intervention

Procedure:
• Lord´s procedure

• Sclerotherapy

Locations

Country	Name	City	State
Norway	Drammen Hospital	Drammen
Sweden	Falu lasarett	Falun	Dalarna
Sweden	Helsingborgs sjukhus	Helsingborg	Skåne
Sweden	Sunderby Hospital	Lulea
Sweden	Östersunds hospital	Östersund	Jämtland
Sweden	Sundsvalls hospital	Sundsvall	Västernorrland
Sweden	Umea University Hospital	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion symptomatic scrotal complaints without recurrence of hydrocele		6 months	No
Other	Proportion treatment failure	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	No
Other	Mean number of treatments until cure		6 months	No
Other	Mean days on sick leave		30 days	No
Other	Proportion cured by solely emptying the hydrocele	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	No
Other	Description of inconvenience grade of patients with hydrocele	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	No
Primary	Cure from symptomatic hydrocele within 6 months of randomization		Every 3 months until 6months from randomization	No
Secondary	Postoperative complications		Within 30 days from treatment	Yes