| Methods |
Randomization by marking 102 sheets with one of the methods (51 for each arm), which were sealed in sequentially‐numbered envelopes. Blinding was not reported for outcome assessor or the participants. Two randomization envelopes were opened by mistake (both for no‐scalpel arm) and were not replaced. One post‐randomization exclusion was reported (no‐scalpel arm) due to inability to perform vasectomy under local anesthetic because of a high testis. Two men assigned to no‐scalpel were converted to bilateral incision during the procedure. High lost to follow‐up rate for the one‐month survey (7 men in the incisional group and 7 men in the no‐scalpel group; 13%) and for the 3‐month assessment for azoospermia (13 men in each group; 74%). |
| Participants |
100 participants aged 31 to 44 years at one site in Denmark from July 1998 to January 2000. The inclusion and exclusion criteria were not stated. |
| Interventions |
Vasectomy with bilateral incision (N=51) versus vasectomy with no‐scalpel approach to the vas (N=49). The methods of vas occlusion and anesthesia were not stated. |
| Outcomes |
The outcome measures included vasectomy success as defined as azoospermia at 3 months, duration of procedure, pain and discomfort (measured with Visual Analog Scales immediately following the procedure), adverse events, need for assistance from another doctor and conversion to another type of procedure. Participants were sent a survey at 1 month regarding pain and wound problems. Participants were to return at 3 months for semen analysis to establish azoospermia. Postoperatively, the resected tissues were sent for microscopic evaluation of the vasectomy. Semen analysis methods were not described. |
| Notes |
The paper was reported in Danish and translated into English. None of the 8 operators (senior resident or fellow) had substantial experience in the no‐scalpel technique. Training was limited to a viewing of an instructional video and one supervised procedure. Only one surgeon performed more than 10 no‐scalpel vasectomies in the trial. Analysis was according to intent‐to‐treat principle exception for one post‐randomization exclusion (due to inability to perform either procedure). The authors reported a priori sample size calculation, but it was based on unrealistic numbers (i.e., 80% power to detect a 19% difference in effect rates between groups at the 5% alpha level). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
