Table 5.
Morbidity at six weeks after procedure* and incidence of clinically significant anxiety and depression by trial arm†. Figures are numbers (percentages) unless stated otherwise
| Biopsy and recall (n=361‡) | Immediate large loop excision (n=400§) | Difference in % between arms (95% CI) | P value | |
|---|---|---|---|---|
| Pain: | ||||
| Any pain | 143 (39.7) | 153 (38.7) | −1.0 (−8.0 to 6.0) | 0.781 |
| Median (IQR) duration (days) | 2 (1-3) | 2 (1-3) | 0.782 | |
| Moderate or more severe | 68 (19.0) | 75 (19.2) | 0.2 (−5.4 to 5.9) | 0.935 |
| Bleeding: | ||||
| Any bleeding | 182 (50.4) | 171 (43.5) | −6.9 (−14.0 to 0.2) | 0.058 |
| Median (IQR) duration (days) | 3 (2-5) | 8 (3-20) | <0.001 | |
| Moderate or more severe | 55 (15.3) | 84 (21.9) | 6.5 (1.0 to 12.1) | 0.022 |
| Discharge: | ||||
| Any discharge | 122 (33.9) | 139 (35.3) | 1.3 (−5.5 to 8.1) | 0.709 |
| Median (IQR) duration (days) | 3 (2-7) | 9 (3-14) | <0.001 | |
| Moderate or more severe | 46 (12.8) | 84 (21.4) | 8.6 (3.2 to 13.9) | 0.002 |
| Anxiety¶ | 32 (9.4) | 26 (6.8) | −2.6 (−6.6 to 1.4) | 0.203 |
| Depression** | 27 (7.9) | 22 (5.7) | −2.2 (−5.9 to 1.5) | 0.239 |
IQR=interquartile range.
*Questionnaires administered about six weeks after last procedure, whether colposcopy, punch biopsies, or large loop excision, to 502 women in biopsy and recall arm and 487 in immediate large loop excision arm.
†Intention to treat analyses. Biopsy and recall group includes women managed by colposcopy only, colposcopy and punch biopsies, or colposcopy, punch biopsies, and large loop excision; immediate large loop excision group includes women managed by colposcopy only, or colposcopy and large loop excision.
‡Number who responded to questionnaire; number who responded to individual questions on pain, bleeding, and discharge varied between 358 and 361; anxiety based on 341 respondents; depression based on 343 respondents.
§Number who responded to questionnaire; numbers who responded to individual questions on pain, bleeding, and discharge varied between 385 and 395; anxiety based on 382 respondents; depression based on 387 respondents.
¶≥11 on hospital anxiety and depression scale anxiety subscale.
**≥8 on hospital anxiety and depression scale depression subscale.