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

Not Applicable

• Conditions: Testicular Hydrocele
• Interventions: Procedure: Lord´s procedure; Procedure: Sclerotherapy

• Registration Number: NCT02082613
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-10
• Study Start: 2015-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-07
• Primary Completion: 2016-12
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lord´s procedure	Lord´s procedure	Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions
Sclerotherapy	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.

Primary Outcome Measures

Name	Time	Method
Cure from symptomatic hydrocele within 6 months of randomization	Every 3 months until 6months from randomization

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Within 30 days from treatment

Trial Locations

Locations (7)

Sundsvalls hospital; 🇸🇪 Sundsvall, Västernorrland, Sweden

Östersunds hospital; 🇸🇪 Östersund, Jämtland, Sweden

Falu lasarett; 🇸🇪 Falun, Dalarna, Sweden

Helsingborgs sjukhus; 🇸🇪 Helsingborg, Skåne, Sweden

Sunderby Hospital; 🇸🇪 Lulea, Sweden

Umea University Hospital; 🇸🇪 Umea, Sweden

Drammen Hospital; 🇳🇴 Drammen, Norway