Table 2.
Secondary outcomes
| Stapled haemorrhoidopexy (n=388) | Traditional excisional surgery (n=386) | Effect size | 95% CI | p value | |||
|---|---|---|---|---|---|---|---|
| Cleveland incontinence score | |||||||
| Baseline | 4·3 (3·9); 376 | 4·1 (4·0); 376 | .. | .. | .. | ||
| 6 weeks | 5·1 (4·5); 288 | 5·0 (4·3); 290 | −0·16 | (−0·74 to 0·42) | 0·58 | ||
| 12 months | 4·4 (4·3); 266 | 2·9 (3·5); 247 | 1·20 | (0·58 to 1·81) | 0·0001 | ||
| 24 months | 3·8 (3·8); 249 | 3·0 (3·4); 235 | 0·79 | (0·15 to 1·42) | 0·0149 | ||
| Haemorrhoid symptom score | |||||||
| Baseline | 10·8 (4·7); 370 | 10·4 (4·7); 370 | .. | .. | .. | ||
| 6 weeks | 8·2 (5·1); 288 | 7·9 (5·0); 291 | 0·15 | (−0·60 to 0·91) | 0·69 | ||
| 12 months | 6·6 (5·1); 263 | 4·3 (4·3); 243 | 2·09 | (1·28 to 2·90) | <0·0001 | ||
| 24 months | 6·4 (5·0); 250 | 4·8 (4·4); 240 | 1·46 | (0·64 to 2·28) | 0·0005 | ||
| SF-36 | |||||||
| Physical component summary | |||||||
| Baseline | 48·5 (9·4); 380 | 48·8 (9·5); 377 | .. | .. | .. | ||
| 6 weeks | 48·2 (10·4); 294 | 48·9 (9·2); 293 | −0·58 | (−1·77 to 0·61) | 0·34 | ||
| 12 months | 49·7 (10·1); 265 | 51·2 (9·4); 255 | −1·79 | (−3·06 to −0·51) | 0·0059 | ||
| 24 months | 50·3 (10·1); 250 | 51·1 (9·4); 234 | −1·15 | (−2·47 to 0·16) | 0·0860 | ||
| Mental component summary | |||||||
| Baseline | 48·8 (11·7); 380 | 49·6 (11·0); 377 | .. | .. | .. | ||
| 6 weeks | 47·3 (12·7); 294 | 48·7 (11·7); 293 | −0·55 | (−2·07 to 0·97) | 0·48 | ||
| 12 months | 48·8 (12·2); 265 | 51·2 (10·4); 255 | −1·71 | (−3·34 to −0·08) | 0·0396 | ||
| 24 months | 49·8 (11·2); 250 | 51·0 (10·9); 234 | −0·89 | (−2·57 to 0·80) | 0·30 | ||
| Tenesmus | |||||||
| 6 weeks | |||||||
| Participants followed up | 309 | 305 | .. | .. | 0·0010 | ||
| Always | 17 (6%) | 9 (3%) | .. | .. | .. | ||
| Often | 42 (14%) | 20 (7%) | .. | .. | .. | ||
| Sometimes | 82 (27%) | 75 (25%) | .. | .. | .. | ||
| Rarely | 58 (19%) | 68 (22%) | .. | .. | .. | ||
| Never | 109 (35%) | 131 (43%) | .. | .. | .. | ||
| Missing | 1 (<1%) | 2 (1%) | .. | .. | .. | ||
| 12 months | |||||||
| Participants followed up | 295 | 278 | .. | .. | <0·0001 | ||
| Always | 11 (4%) | 4 (1%) | .. | .. | .. | ||
| Often | 27 (9%) | 7 (3%) | .. | .. | .. | ||
| Sometimes | 60 (20%) | 46 (17%) | .. | .. | .. | ||
| Rarely | 65 (22%) | 43 (15%) | .. | .. | .. | ||
| Never | 113 (38%) | 154 (55%) | .. | .. | .. | ||
| Missing | 19 (6%) | 24 (9%) | .. | .. | .. | ||
| 24 months | |||||||
| Participants followed up | 288 | 274 | .. | .. | 0·0012 | ||
| Always | 6 (2%) | 3 (1%) | .. | .. | .. | ||
| Often | 27 (9%) | 13 (5%) | .. | .. | .. | ||
| Sometimes | 51 (18%) | 36 (13%) | .. | .. | .. | ||
| Rarely | 55 (19%) | 47 (17%) | .. | .. | .. | ||
| Never | 119 (41%) | 143 (52%) | .. | .. | .. | ||
| Missing | 30 (10%) | 32 (12%) | .. | .. | .. | ||
Data are n (%) or mean (SD); n. 6 weeks refers to time since sugery and 12 months and 24 months refers to time since randomisation. Effect sizes are mean differences. SF-36=36-item Short Form Health Survey. Always=one or more times daily. Often=more than once a week but less than once daily. Sometimes=more than once a month but less than once a week. Rarely=less than once a month. Missing=question not completed.