Table 1.
Trial characteristics | Trial 1 | Trial 2 | Trial 3 |
---|---|---|---|
Clinical condition | Vaginal prolapse | Haemorrhoids | Ureteric stones |
Trial design | RCT and comprehensive cohort | Simple parallel design | Simple parallel design |
Sample size, N (n) | 4,500 (2,250 randomised) | 800 | 1,200 |
Recruitment rate (%) | 49 | 74 | 56 |
Arms | 3 in each repair arm (4 different interventions) | 2 | 3 |
Intervention | Surgery (RCT split by primary or secondary repair | Surgery | Drug |
Primary repair randomisation | 1. Traditional excisional haemorrhoidectomy | 1. Calcium channel blocker | |
1. Standard repair | 2. Stapled haemorrhoidopexy | 2. α blocker | |
2. Standard repair with biological mesh | 3. Placebo | ||
3. Standard repair with nonabsorbable mesh | |||
Secondary repair randomisation | |||
1. Standard repair | |||
2. Standard repair with nonabsorbable mesh | |||
3. New repair with mesh kit | |||
Blinding | Participants and outcome assessors (for patient-reported outcomes) | Participants and outcome assessors (for patient-reported outcomes) | Participants, caregivers and outcome assessors |
Number of sites | 15 | 31 | 24 |
Primary outcome (clinical or patient-reported and timing) | Patient-reported at 2 years postrandomisation | Patient-reported at 2 years postrandomisation | Clinical at 4 weeks and patient-reported at 12 weeks postrandomisation |
Parent trial participant characteristics | |||
Median age (IQR) | 61 (52 to 68) | 49 (20 to 40) | 44 (34 to 52) |
Sex (% females) | 100 | 48 | 19 |
aRCT, Randomised controlled trial.