|
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
|
