Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/09/2015
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 Alan Horgan

ORCID ID

Contact details

Consultant Colorectal Surgeon
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0503191877

Study information

Scientific title

Improving early nutritional intake and functional outcome in postoperative colorectal surgical patients: A randomised clinical trial

Acronym

Study hypothesis

Not provided at time of registration

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: Colorectal

Intervention

1. Intervention group: to receive postoperative prescribed supplementation (ProCal) and standard diet
2. Control group: to receive standard diet only

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Muscle strength at discharge measured using handgrip dynamometry.

Secondary outcome measures

1. Daily calorie intake
2. Nausea as indicated on a visual analogue scale
3. Days to first flatus
4. Days to first bowel movement
5. Serum albumin levels
6. Length of hospital stay

Overall trial start date

01/04/2007

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible participants are all consecutive patients undergoing elective colorectal surgery in the Freeman Hospital, Newcastle upon Tyne.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

46

Participant exclusion criteria

1. Any patient with dementia
2. Lactose intolerance
3. Pregnancy
4. Diabetes mellitus
5. Age under 16 years
6. Musculoskeletal conditions preventing accurate use of the handgrip dynamometer
7. Any patient unable to feed orally pre-operatively

Recruitment start date

01/04/2007

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Colorectal Surgeon
Newcastle upon Tyne
NE7 7DN
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

Newcastle upon Tyne Hospitals NHS Trust (UK), no external funding given to 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