Ligasure haemorrhoidectomy versus conventional diathermy haemorrhoidectomy: one year follow up
| ISRCTN | ISRCTN31135824 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31135824 |
| Protocol serial number | N0436125589 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr D G Jayne
Scientific
Scientific
Academic Unit of Surgeons
Level 8
Clinical Sciences Building
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 2065122 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the long-term results of ligasure with conventional diathermy haemorrhoidectomy in the treatment of symptomatic grade III and IV haemorrhoids. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Haemorrhoidectomy |
| Intervention | Randomised controlled trial; Before-after trial. Random Allocation to: 1. Ligasure 2. Conventional Treatment |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Anorectal physiology and endoanal ultrasound were not included in the original trial so there is no data for direct comparison. However this information is important to correlate patient symptomatology with quantitative assessment of sphincter anatomy and function. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | All 40 previous participants of the Ligasure versus conventional diathermy study |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Unit of Surgeons
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/07/2005 | Yes | No |
