Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/08/2015
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 M E Gaunt

ORCID ID

Contact details

West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0274181489

Study information

Scientific title

PIN (Perforate Invaginate) stripping of the long saphenous vein, in patients having varicose vein surgery, with or without groin dissection on the postoperative pain outcome: prospective, single blind, randomised controlled trial

Acronym

Study hypothesis

What are the outcomes of PIN (Perforate Invaginate) stripping of the long saphenous vein in patients having varicose vein surgery with or without groin dissection on postoperative pain?

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Long saphenous vein

Intervention

Patients were randomised to groin dissection (conventional practice) or no groin dissection (intervention group).

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Numerical analogue pain score at 1, 6 and 12 hours post-op.

Secondary outcome measures

Analgesic requirements during first 24 hours post-op and first week post-op.

Overall trial start date

15/04/2005

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with sapheno-femoral incompetence and long saphenous vein incompetence in thigh who are undergoing elective sapheno-femoral disconnection and PIN stripping of the long saphenous vein with multiple avulsions.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

25 in each group. 50 total.

Participant exclusion criteria

Patients scheduled to undergo simultaneous saphenous vein surgery.

Recruitment start date

15/04/2005

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
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

Government

Website

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

Funders

Funder type

Government

Funder name

West Suffolk Hospitals NHS Trust (UK), NHS R&D support funding

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