| Methods |
Randomized controlled trial. The method of randomization, the use of allocation concealment and blinding of the participant or outcome assessor was not reported.
Lost to follow‐up rates and exclusions after randomization were not described. |
| Participants |
100 participants aged 35 to 50 years in a hospital setting in India. Inclusion criteria were healthy men requesting sterilization ages 35 to 50 years.
Exclusion criteria were not stated. |
| Interventions |
Vas occlusion with 2 tantalum clips (Hemo Clips) with no transection of the vas versus vasectomy (transection of the vas with both ends of the vas tied and looped back). |
| Outcomes |
The primary outcome measure was failure to achieve azoospermia. Other outcome measures were adverse events and consumer acceptability. |
| Notes |
The report does not provide an a priori hypothesis or a sample size calculation.
Analysis was probably not according to intention‐to‐treat principle, but it is not possible to determine due to inadequate reporting. Antibiotics were administered as prophylaxis. The intervention changed part way through the study. Initially one clip was used, but after vasograms showed leakage from the vas one was added. The paper does not account for at what point in the study this occurred. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
no information |
