Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/08/2015
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 U R Nair

ORCID ID

Contact details

Yorkshire Heart Centre
Jubilee Building
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 5792
Unnikrishnan.Nair@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130522

Study information

Scientific title

Assessment of pain and other benefits following ministernotomy for cardiac surgery: a prospective randomised trial

Acronym

Study hypothesis

To determine the benefit obtained in patients who underwent ministernotomy for cardiac surgery.

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: Cardiovascular

Intervention

Random allocation to [a] treatment a [b] treatment b (Small chest incision vs full chest incision).

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Pain, total blood loss, analgesia requirement, lung function.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All adult cardiac surgical cases under the care of Mr R U Nair requiring sternotomy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2003

Recruitment end date

01/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Yorkshire Heart Centre
Leeds
LS1 3EX
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

Government

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

Publication citations

Additional files

Editorial Notes