Use of aspiration as an intervention for filarial hydrocele

INTERVENTION: 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 participants for the study will be recruited and assigned a study identification number (ID). The study ID and hydrocele stage information of the eligible participants will then be sent to the data management team in Bonn who will assign the IDs to a randomization code. Participants with hydrocele stage 2 will be separately randomized from participants with hydrocele stages 3 or 4 in order to obtain equally distributed numbers of the different stages in each study arm. In case of patients with bilateral hydrocele, the side with the higher volume will always be taken into account for randomization arm allocation. The codes will be retrieved from a computer‐generated randomization list. After randomization in Bonn, the team in Ghana will be informed in writing about the study arm assignment of each individual participant. This procedure assures that the assignment of the participants to the respective intervention arms will not be biased by any personal involvement. After randomization, the intervention can be initiated according to the randomization code. Participants will be randomly assigned into one of the two study groups: Intervention group (Group A) n = 30: ultrasound‐guided aspiration of hydrocele fluid at study onset. Control group (Group B) n = 30: no intervention at study onset; 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 aspiration procedure will be CONDITION: Hydrocele due to lymphatic filariasis ; Urological and Genital Diseases ; Hydrocele, unspecified PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: ; 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;