Primary outcome | | | | |
Major AEs, n/N (%) | 0/978 (0.0) | 1/984 (0.1) | 0.0005 (0.00007, 0.0036) | .32 |
Secondary outcomes | | | | |
Major and minor AEs at different time points during the study, n/N (%) | | | | |
Intraoperatively | 0/978 (0.0) | 0/984 (0.0) | NA | NA |
Immediately postoperative | 0/978 (0.0) | 0/984 (0.0) | NA | NA |
3 days postoperative | 1/969 (0.1) | 0/976 (0.0) | 0.0005 (0.000072, 0.0036) | .32 |
7 days postoperative | 2/976 (0.2) | 3/975 (0.3) | 1.5 (0.3, 8.9) | .66 |
Unscheduled postoperative visitsa | 1/4 (25.0) | 3/13 (23.1) | 0.80 (0.2, 3.0) | .94 |
Performance of tubal occlusion by minilaparotomy | | | | |
Time to complete procedure, minutes, mean (SD [range]) | 26.0 (1.0 [14, 65]) | 26.0 (1.0 [15, 90) | NA | .42 |
Requested verbal instruction from the supervisor due to difficulty performing the procedure,b n/N (%) | 15/978 (1.5) | 20/984 (2.0) | 0.75 (0.36, 1.56) | .40 |
Requested the supervisor assist with the procedure,c n/N (%) | 14/978 (1.4) | 13/984 (1.3) | 1.08 (0.47, 2.52) | .80 |
Inability to complete procedure,d n/N (%) | 2/978 (0.2) | 0/984 (0.0) | NA | .25 |
Maximum pain during procedure,e mean (SD) | 4.12 (2.4) | 4.11 (2.4) | NA | .98 |
Participant very satisfied with minilaparotomy, n/N (%) | 834/969 (86.1) | 831/976 (85.1) | 1.01 (0.88, 1.15) | .34 |
Self-efficacy of providers in performing minilaparotomy,f mean (SD) | | | | |
General self-efficacy | 32.3 (6.1) | 31.3 (7.5) | NA | .79 |
Confidence | 10.9 (0.9) | 11.5 (0.8) | NA | .21 |
Comfort | 11.4 (0.5) | 10.9 (1.7) | NA | .41 |