se of aspiration as an intervention for filarial hydrocele

Not Applicable

• Conditions: Hydrocele due to lymphatic filariasis; Urological and Genital Diseases; Hydrocele, unspecified

• Registration Number: ISRCTN13249715
• Lead Sponsor: Kumasi Centre for Collaborative Research (KCCR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-08
• Last Update Posted: 21 March 2022
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Ultrasound determined hydrocele stage 2 – 4 as described by Debrah et al., 2007, however, participants with stage 4 should not have fluid volume more than 500 ml as determined by ultrasound
2. Male patients aged 18 - 55 years
3. Resident in the endemic area for 2 years or more
4. Able and willing to give informed consent to participate in the study

Exclusion Criteria

1. Age <18 or >55 years
2. No hydrocele or stage 1 hydrocele(s) only
3. Hydrocele of unknown cause
4. Stage 4 hydrocele with a fluid volume >500 ml determined by ultrasound and other stages that require hydrocelectomy
5. Thickened, fibrosed or calcified tunica vaginalis assessed by ultrasound
6. Haemorrhagic fluid or necrotic testis(es) assessed by ultrasound
7. Resident in the area for <2 years
8. Hernia assessed by ultrasound
9. History of bleeding tendencies
10. History of haemophilia
11. Chronic liver disease
12. Coagulopathies
13. History of severe allergic reaction or anaphylaxis due to anaesthetic drugs
14. Participation in drug trials concurrent with this study
15. Any other condition or severe comorbidities (except for features of the filarial disease) that, in the opinion of the study clinician, would risk the safety or rights of a participant or would render the subject unable to comply with the protocol.
16. Intake of blood thinners (warfarin, heparin, aspirin)
17. Intake of diuretics
18. Unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of hydrocele stage, assessed using ultrasound and defined as a reduction in at least one hydrocele stage, between pre-aspiration and 12 months after aspiration