Table 1 Characteristics of trials included in the DelibeRATE study ^a

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