Condition category
Circulatory System
Date applied
05/05/2008
Date assigned
23/06/2008
Last edited
10/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Malcolm Loudon

ORCID ID

Contact details

Ward 50
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

Treatment with stapled haemorrhoidopexy produces better symptom control and less recurrent disease compared to rubber band ligation; both are considered to treat the disease in a similar mechanism of fixing the haemorrhoidal cushion without excising them.

Ethics approval

Ethics approval received from the Grampian Research Ethics Committee on the 11th August 2002 (ref: 01/0297).

Study design

Single centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Circumferential grade II symptomatic haemorrhoids

Intervention

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 recurrence of disease, a repeat treatment can be given. The rubber band ligation can be repeated up to four times at six-week intervals, before being declared failure of treatment. Similarly, the stapled haemorrhoidopexy will be repeated up to two more times before declared as failure of treatment.

Total follow-up is up to one year including 6-week and 26-week follow-ups in between.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Disease recurrence at six weeks and one year.

Secondary outcome measures

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.

Overall trial start date

20/10/2002

Overall trial end date

02/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Circumferential grade II symptomatic haemorrhoids irrespective of age and gender.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

60

Participant exclusion criteria

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

Recruitment start date

20/10/2002

Recruitment end date

02/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ward 50
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

Medicines Assessment Research Unit (MARU) (UK)

Sponsor details

c/o Mr MA Loudon and Mr AJM Watson
Grampian Hospitals NHS Trust
Aberdeen Royal Infirmary
Ward 50
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nhsgrampian.org

Funders

Funder type

Hospital/treatment centre

Funder name

Ethicon Endo-Surgery (Europe) GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19508532

Publication citations

  1. Results

    McKenzie L, de Verteuil R, Cook J, Shanmugam V, Loudon M, Watson AJ, Vale L, Economic evaluation of the treatment of grade II haemorrhoids: a comparison of stapled haemorrhoidopexy and rubber band ligation., Colorectal Dis, 2010, 12, 6, 587-593, doi: 10.1111/j.1463-1318.2009.01889.x.

Additional files

Editorial Notes