Hydrocele due to lymphatic filariasis Urological and Genital Diseases Hydrocele, unspecified
Conditions
Interventions
After screening, volunteers who meet the inclusion criteria will be randomly assigned to one of the two study arms. Randomization to the study arms will be conducted by central randomization. The part
if this method proves to be effective, ultrasound-guided aspiration will be offered at the end of the study.
For each participant in the intervention group (A), the ultrasound-guided
Sponsors
Kumasi Centre for Collaborative Research (KCCR)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: 1. Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of hydrocele stage, defined as a reduction in at least one hydrocele stage at 6, 12, or 18 months after aspiration. Hydrocele stage is measured using ultrasound, as defined by Debrah et al., 2007 2. Improvement of hydrocele size by comparing the testis to scrotum ratio at 6, 12 and 18 months post-aspiration. An increase in the ratio will be defined as an improvement (quantitatively calculated as described by Turgut et al., 2007) 3. Improvement of hydrocele stage (staging according to the recommended WHO guidelines) at 6, 12 or 18 months post-aspiration. Improvement is defined as a reduction of at least one hydrocele stage 4. Change of the grade of penis burial between pre-aspiration and 6, 12 and 18 months post-aspiration, defined on a scale of 0-4, with 0 being no burial and 4 being complete burial (grading according to WHO surgical approached to LF hydrocele) 5. Curative effect, defined as no fluid accumulation (no relapse) determined using ultrasound after aspiration, measured at 6, 12 and 18 months after aspiration | — |
Countries
Ghana
Contacts
Public ContactAlexander Debrah
Outcome results
None listed