Randomised controlled trial comparing two treatment methods for symptomatic haemorrhoidal disease
| ISRCTN | ISRCTN23585705 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23585705 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/05/2008
- Registration date
- 23/06/2008
- Last edited
- 09/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Malcolm Loudon
Scientific
Scientific
Ward 50
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Study information
| Study design | Single centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised trial of stapled haemorrhoidopexy versus rubber band ligation in the treatment of circumferential symptomatic grade II haemorrhoids |
| Study objectives | 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(s) | Ethics approval received from the Grampian Research Ethics Committee on the 11th August 2002 (ref: 01/0297). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 20/10/2002 |
| Completion date | 02/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Circumferential grade II symptomatic haemorrhoids irrespective of age and gender. |
| Key exclusion criteria | 1. Associated anaorctal sepsis 2. Associated colonic malignancy or inflammatory bowel disease 3. Associated anal sphincter pathology |
| Date of first enrolment | 20/10/2002 |
| Date of final enrolment | 02/04/2005 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Ward 50
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
University of Aberdeen Medicines Assessment Research Unit (MARU)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr MA Loudon and Mr AJM Watson
Grampian Hospitals NHS Trust
Aberdeen Royal Infirmary
Ward 50
Foresterhill
Aberdeen
AB25 2ZN
Scotland
United Kingdom
| Website | http://www.nhsgrampian.org |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Hospital/treatment centre
Ethicon Endo-Surgery (Europe) GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | Yes | No |
Editorial Notes
09/01/2020: Internal review.
