Outcome measure | Single arm trial | Feasibility RCT | ||||
---|---|---|---|---|---|---|
Baseline, n (%) | Follow-up, n (%) | Control | Intervention | |||
Baseline, n (%) | Follow-up, n (%) | Baseline, n (%) | Follow-up, n (%) | |||
Do you have pain associated with your bulge/hernia? | ||||||
 Yes | 7 (87.5) | 8 (100) | 2 (50.0) | 1 (25.0) | 3 (75.0) | 1 (25.0) |
 No | 1 (12.5) | 0 | 2 (50.0) | 3 (75.0) | 1 (25.0) | 3 (75.0) |
If yes, what is your pain score (mean (SD)) | 4.71 (2.87) | 4.88 (3.09) | 2.00 (1.41) | 7.00 | 1.33 (0.58) | 1.00 |
Does your pain affect any of the following? | ||||||
 Being active or participating in your hobbies | 6 (75.0) | 6 (75.0) | 0 | 1 (25.0) | 0 | 0 |
 Completing your day-to-day activities | 6 (75.0) | 6 (75.0) | 0 | 1 (25.0) | 0 | 0 |
 Lifting items you find heavy | 6 (75.0) | 7 (87.5) | 1 (25.0) | 1 (25.0) | 2 (50.0) | 0 |
 Doing your job | 2 (25.0) | 1 (12.5) | 0 | 0 | 0 | 0 |
 Others | 0 | 0 | 1 (25.0) | 0 | 0 | 0 |
What size do you consider your bulge/hernia to be? | ||||||
 Small | 2 (25.0) | 1 (12.5) | 0 | 0 | 1 (25.0) | 2 (50.0) |
 Medium | 3 (37.5) | 3 (37.5) | 3 (75.0) | 0 | 2 (50.0) | 2 (50.0) |
 Large | 2 (25.0) | 3 (37.5) | 1 (25.0) | 3 (75.0) | 0 | 0 |
 Very large | 1 (12.5) | 1 (12.5) | 0 | 1 (25.0) | 1 (25.0) | 0 |
Is your bulge/hernia larger than 5Â cm in diameter? | ||||||
 Yes | 7 (87.5) | 6 (75.0) | 3 (75.0) | 4 (100.0) | 2 (50.0) | 2 (50.0) |
 No | 1 (12.5) | 2 (25.0) | 1 (25.0) | 0 | 2 (50.0) | 2 (50.0) |
Do you use any of the following to help manage your bulge/hernia? | ||||||
 Support garments | 8 (100) | 8 (100) | 3 (75.0) | 3 (75.0) | 4 (100.0) | 4 (100.0) |
 Exercises | 5 (62.5) | 6 (75.0) | 0 | 1 (25.0) | 0 | 4 (100.0) |
 Dietary management or restriction | 3 (37.5) | 4 (50.0) | 0 | 0 | 0 | 0 |
 Others | 0 | 0 | 0 | 0 | 0 | 0 |
Does your bulge/hernia affect any of the following? | ||||||
 Your stoma output | 2 (25.0) | 3 (37.5) | 0 | 1 (25.0) | 2 (50.0) | 0 |
 Your bag adherence | 1 (12.5) | 2 (25.0) | 3 (75.0) | 3 (75.0) | 1 (25.0) | 2 (50.0) |
 Other bag issues | 0 | 1 (12.5) | 2 (50.0) | 0 | 1 (25.0) | 1 (25.0) |
 The food you eat | 3 (37.5) | 3 (37.5) | 1 (25.0) | 0 | 0 | 0 |
 Others | 0 | 1 (12.5) | 0 | 0 | 1 (25.0) | 0 |
Have you ever considered surgical repair? | ||||||
 Yes | 3 (37.5) | 3 (37.5) | 2 (50.0) | 1 (25.0) | 2 (50.0) | 3 (75.0) |
 No | 5 (62.5) | 4 (50.0) | 2 (50.0) | 1 (25.0) | 2 (50.0) | 1 (25.0) |
Are you currently considering surgical repair? | ||||||
 Yes | 2 (25.0) | 3 (37.5) | 1 (25.0) | 1 (25.0) | 1 (25.0) | 2 (50.0) |
 No | 6 (75.0) | 5 (62.5) | 3 (75.0) | 2 (50.0) | 3 (75.0) | 2 (50.0) |