Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
17/10/2016
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 A Abdulgader

ORCID ID

Contact details

LIMIT - Leeds Institute for Minimally Invasive The
6th Floor
Wellcome Wing
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 3557
abdulmoniem.abdulgader@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436165617

Study information

Scientific title

LigaSure technique of haemorrhoidectomy versus Ferguson Clinic haemorrhoidectomy: a randomised prospective study

Acronym

Study hypothesis

The study is designed to compare Ferguson clinic closed haemorrhoidectomy with LigaSure haemorrhoidectomy. The primary end points of the study is the assessment of postoperative pain, morbidity and time to full recovery.

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

Surgery: Haemorrhoidectomy

Intervention

Ferguson clinic closed haemorrhoidectomy vs LigaSure haemorrhoidectomy.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Visual analogue of postoperative pain on a daily basis for one week, followed by pain scores at two and four weeks as well as overall satisfaction
2. Pre and postoperative anorectal physiology and endoanal ultrasonography (12 weeks post operative)
3. Postoperative complications: a) infection; b) wound dehiscence; c) haemorrhage

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects with history of 3rd degree haemorrhoids.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

LIMIT - Leeds Institute for Minimally Invasive The
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Not defined

Website

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

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust

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

Publication citations

Additional files

Editorial Notes

17/10/2016: No publications found in PubMed, verifying study status with principal investigator.