Randomised controlled trial comparing two treatment methods for symptomatic haemorrhoidal disease

A randomised trial of stapled haemorrhoidopexy versus rubber band ligation in the treatment of circumferential symptomatic grade II haemorrhoids

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23585705

Enrollment

Registered

2008-06-23

Start date

2002-10-20

Completion date

Unknown

Last updated

2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circumferential grade II symptomatic haemorrhoids Circulatory System Haemorrhoids

Interventions

1. Rubber band ligation 2. Stapled haemorrhoidopexy Both arms are treated as a one-off to begin with and then reviewed at six weeks. As per the protocol, If there is a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Circumferential grade II symptomatic haemorrhoids irrespective of age and gender.

Exclusion criteria

Exclusion criteria: 1. Associated anaorctal sepsis 2. Associated colonic malignancy or inflammatory bowel disease 3. Associated anal sphincter pathology

Design outcomes

Primary

Measure	Time frame
Disease recurrence at six weeks and one year.	—

Secondary

Measure	Time frame
1. Symptom score (validated and published already) 2. Cleveland continence score 3. Quality of life score (36-item Short Form health survey [SF-36], EuroQoL instrument [EQ-5D] and Hospital Anxiety and Depression Scale [HAD] scores) 4. Cost effectiveness 5. Sphincter damage All secondary outcomes were assessed at 6 weeks, 26 weeks and one year.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026