|
ISRCTN
|
ISRCTN28708390
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
LigaSure technique of haemorrhoidectomy versus Ferguson Clinic haemorrhoidectomy: a randomised prospective study
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0436165617
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Surgery: Haemorrhoidectomy
|
|
Participants - inclusion criteria
|
Subjects with history of 3rd degree haemorrhoids.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2003
|
|
Anticipated end date
|
01/01/2004
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Ferguson clinic closed haemorrhoidectomy vs LigaSure haemorrhoidectomy.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Leeds Teaching Hospitals NHS Trust
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
-
Abdulgader
|
|
Address
|
LIMIT - Leeds Institute for Minimally Invasive The
6th Floor, Wellcome Wing
Great George Street
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS1 3EX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 0113 392 3557
|
|
Fax
|
+44 0113 392 6305
|
|
Email
|
abdulmoniem.abdulgader@leedsth.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
24/10/2007
|
|
Date ISRCTN assigned
|
28/09/2007
|
