Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/10/2009
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 D G Jayne

ORCID ID

Contact details

Academic Unit of Surgeons
Level 8
Clinical Sciences Building
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 2065122
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436125589

Study information

Scientific title

Acronym

Study hypothesis

To compare the long-term results of ligasure with conventional diathermy haemorrhoidectomy in the treatment of symptomatic grade III and IV haemorrhoids.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Haemorrhoidectomy

Intervention

Randomised controlled trial; Before-after trial. Random Allocation to:
1. Ligasure
2. Conventional Treatment

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2003

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All 40 previous participants of the Ligasure versus conventional diathermy study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/03/2003

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Surgeons
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15932557

Publication citations

  1. Results

    Peters CJ, Botterill I, Ambrose NS, Hick D, Casey J, Jayne DG, Ligasure trademark vs conventional diathermy haemorrhoidectomy: long-term follow-up of a randomised clinical trial., Colorectal Dis, 2005, 7, 4, 350-353, doi: 10.1111/j.1463-1318.2005.00817.x.

Additional files

Editorial Notes