Table 1.
Outcomes for participants undergoing Shang Ring or Forceps-guided Adult Male Circumcision by both Intention to Treat and As-Treated Analyses
| Intention to Treat analysis | As Treated Analysis | |||||||
|---|---|---|---|---|---|---|---|---|
| Outcome (%) | Shang Ring (n=73) | Forceps (n=65) | RR (95%CI) | p-value | Shang Ring (n=66) | Forceps (n=72) | RR (95%CI) | p-value |
| Operative Time < 10 minutes | 71.2 | 0.0 | INF | -- | 78.8 | 0 | INF | -- |
| Operative Time < 30 minutes | 95.6 | 81.5 | 1.18 (1.04 - 1.33) | 0.01 | 97.0 | 81.9 | 1.18 (1.05 – 1.33) | 0.01 |
| Any Major Complication | 0.0 | 0.0 | -- | -- | 0.0 | 0.0 | -- | -- |
| Any Minor Complication | 57.5 | 18.5 | 3.12 (1.80 – 5.40) | <0.01 | 56.1 | 23.6 | 2.37 (1.49 – 3.79) | <0.01 |
| Ring Slippage | 5.5 | N/A | 6.1 | N/A | ||||
| Infection | 31.5 | 7.7 | 4.10 (1.64 - 10.1) | <0.01 | 27.3 | 13.9 | 1.96 (0.98 – 3.95) | 0.06 |
| Any Day 14 Complication | 42.5 | 16.9 | 2.51 (1.37 – 4.59) | <0.01 | 43.9 | 18.1 | 2.43 (1.38 – 4.28) | <0.01 |
| Healed by Day 7 | 12.3 | 13.9 | 0.89 (0.38 – 2.11) | 0.79 | 10.6 | 15.3 | 0.69 (0.29 – 1.69) | 0.42 |
| Healed by Day 14 | 34.3 | 50.8 | 0.67 (0.45 – 1.01) | 0.05 | 33.3 | 50.0 | 0.67 (0.44 – 1.01) | 0.06 |
| Healed by Day 21 | 90.9 | 95.4 | 0.95 (0.86 – 1.04) | 0.26 | 90.9 | 94.4 | 0.96 (0.88 -1.06) | 0.43 |
| Return to Activity Day 1 | 94.5 | 50.8 | 1.86 (1.45 – 2.38) | <0.01 | 95.4 | 54.2 | 1.76 (1.41 – 2.20) | <0.01 |
| Pain Free Post-Op Day 1 | 24.7 | 16.9 | 1.46 (0.74 – 2.86) | 0.27 | 27.3 | 15.3 | 1.79 (0.91 – 3.50) | 0.09 |
| Pain Free Post-Op Day 3 | 69.9 | 62.7 | 1.11 (0.87 – 1.43) | 0.50 | 71.2 | 62.1 | 1.15 (0.90 – 1.46) | 0.27 |
| Pain Free Post-Op Day 7 | 100 | 100 | -- | -- | 100 | 100 | -- | -- |
| High Patient Satisfaction | 74.0 | 60.0 | 1.38 (0.94 – 2.02) | 0.10 | 77.3 | 58.3 | 1.65 (1.04 – 2.60) | 0.03 |