Significance statement
Introduction
Background and rationale
Objectives
Methods and analysis
Trial design
Eligibility criteria
Inclusion criteria
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Grade 1 (symptomatic with rectal blood loss) or grade 2 haemorrhoids (Golligher classification)
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Aged 18 years old or older and legally competent
Exclusion criteria
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Grade 3 and 4 haemorrhoids (Golligher classification)
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Patients that have undergone treatment for HD within the last 12 months, regardless of the type of treatment.
Interventions
Outcomes
Primary outcomes
Tools of measurement | |
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Primary outcomes | |
Patient-related outcomes | PROM (minimal score 5, maximum score 25): The lower the score the better the result |
- Blood loss | Likert scale – 1 (not at all) to 5 (very much) |
- Pain | Likert scale – 1 (not at all) to 5 (very much) |
- Prolapse | Likert scale – 1 (not at all) to 5 (very much) |
- Itching | Likert scale – 1 (not at all) to 5 (very much) |
- Soiling | Likert scale – 1 (not at all) to 5 (very much) |
HISS (minimal score 0, maximum score 20) | |
- Impact on daily activities | Scale – 0 (no impact at all) to 10 (highly impacted on daily activities) |
- Satisfaction with treatment | Scale – 0 (not at all satisfied) to 10 (very satisfied) |
Complications | |
Incontinence | Wexner Fecal Incontinence Score |
Abscess | Physical examinationa |
Fistulation | Physical examinationa |
Urine retention | Bladder scan |
Anal stenosis | Physical examinationa |
Anal fissure | Physical examination |
Arterial bleeding | Physical examination |
Thrombosed haemorrhoid | Physical examination |
Recurrence | Subjective return of initial symptoms |
Secondary outcomes | |
Patient experience | PREM |
Absenteeism | Days of sick leave from work |
Number of treatments | Numeric |
Crossover rate | Numeric |
Treatment efficacy
Secondary outcomes
Participant timeline
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T = day 0 → outpatient clinic treatment with either SCL or RBL after providing written informed consent to the treating physician.
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T = day 7 → telephone appointment with a blinded researcher: the PROM and PREM questionnaires are completed by the researcher.
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T = 6 → weeks outpatient clinic appointment with a physician. The PROM and Wexner incontinence scale are completed together with a physical examination. If needed, the same treatment (SCL or RBL) is repeated.
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T = 6 → months telephone appointment with a blinded researcher: PROM questionnaire completed and (subjective) symptoms related to recurrence are assessed.
Study period | ||||
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Enrolment/allocation | Post-allocation | |||
Time point | Baseline (at allocation or by telephone) | 1 week (telephone) | 6 weeks (outpatient clinic) | 6 months (telephone) |
Eligibility screen | X | |||
Informed consent | X | |||
Allocation (RBL/SCL) | X | X | ||
Primary outcomes | ||||
HD symptoms (PROM) | X | X | X | X |
Abscess | X | |||
Urine retention | X | |||
Anal stenosis | X | |||
Incontinence | X | |||
Fistula | X | |||
Recurrence | X | X | ||
Secondary outcomes | ||||
Satisfaction/experience (PREM) | X | |||
Absenteeism | X | (X) | ||
Number of treatments | X | X | ||
Crossover rate | X |
Sample size calculation
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Significance level (a) = 2.5%
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Power (1-beta) = 80%
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Non-inferiority limit = 10%
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Proportionality group A = 70%
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Proportionality group B = 70%
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Sample size required per group = 330
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Total sample size required = 660
Recruitment and blinding
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The treating physician generates the allocation process or registration to the preference arm, after written informed consent has been provided.
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The randomization sequence will be computer generated with the CastorEDC program (version 24.41) without stratification, with 1:1 allocation to either group, generating a unique record number.
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Both patient and treating physician are not blinded for the treatment arm.
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In concept, the researcher who completes the telephone interviews at 7 days and 6 months is blinded to the given therapy and is instructed not to actively ask patients which treatment they received. However, the data is added in the same database system, so complete blinding is not guaranteed. The physician at T = 0 and T = 6 weeks is not blinded as it is otherwise impossible to complete the treatment. Also, at 6 weeks the treating physician should repeat the initial treatment when necessary, following protocol.