E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas. |
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E.2.2 | Secondary objectives of the trial |
Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. In-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Men and women aged 18 years or older - Eligible for e-mail questionnaires - Sufficient understanding of the Dutch written language (reading and writing) - Obtained written informed consent
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E.4 | Principal exclusion criteria |
- A coexistent perianal fistula - Spontaneous drainage - Secondary or recurrent perianal abscess - Presence of an internal fistula opening - Any additional surgical procedure performed during the same session - Previous (peri)anal surgery - Inflammatory bowel disease - History of radiation of the pelvic area - Anorectal malignancy - Immunodeficiency - Kidney failure, eGFR <30ml/min - Valvular heart disease - Pregnancy or lactation - Antibiotic prophylaxis indicated for another reason - Immunosuppressive medication at the time of surgery - Allergy to metronidazole or ciprofloxacin - Not able or trouble with swallowing pills - Concomitant use of: tizadine, theopylline clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine, amiodarone, erytromcyine, sotalol, azithormycine, citalopram, escitalopram, flecainide, fluconazol, haloperidol >5mg/day, methadone, ondansetron, lithium, lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram, mebendazole, corticosteroids |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measure is development of a perianal fistula. A perianal fistula is diagnosed based on findings from physical examination. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient’s HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient’s health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient’s self-rated health with endpoints labelled ‘the best health you can imagine’ at the top and ‘the worst health you can imagine’ at the bottom. - In-hospital direct and indirect costs (measured with iPCQ and iMCQ) and out-of hospital postoperative costs. - Need of repeated drainage. - Patient related outcome (PRO) are complaint reduction assessed by a proctology specific validated patient-related outcome measure, the proctoPROM(13). This was recently developed and validated at Proctos Clinic. At baseline participants will complete PRO questionnaires. Also at 1 and 6 weeks and 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email with access to a web tool (Castor). If the patient does nog have an email account, the questionnaires will be send the patients’ home address, accompanied by a return envelope provided with postage stamps and the address of the hospital. - Clinical outcome measures; o Data collected during operation include are code(s) of surgeon(s); date of surgery; type of surgery; blood loss in milliliters; ‘skin to skin’ operation time; intraoperative complications. o The following postoperative parameters are collected: Day of discharge from hospital; Complications (postoperative bleeding, urinary retention, emergency reoperation, anal stenosis and fecal incontinence) including death and cause of death, early complications are complications manifested within 7 days post procedure. Complications are considered late complications at 52 weeks (1 year) post-procedure. Early complications include ‘abscess’ and ‘urinary retention’ and will be assessed 7 days post-procedure. ‘Abscess’ will be assessed by physical examination and ‘urinary retention’ by ultrasonography ; further Reason and duration of possible readmission in hospital within 90 days postoperatively. Duration of absence from work. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PROM at 1 and 6 weeks and 6 and 12 months Early complications are complications manifested within 7 days post procedure. Complications are considered late complications at 52 weeks (1 year) post-procedure. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |