Improving early nutritional intake and functional outcome in postoperative colorectal surgical patients: A randomised clinical trial
| ISRCTN | ISRCTN75902444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75902444 |
| Secondary identifying numbers | N0503191877 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 12/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Alan Horgan
Scientific
Scientific
Consultant Colorectal Surgeon
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Improving early nutritional intake and functional outcome in postoperative colorectal surgical patients: A randomised clinical trial |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Colorectal |
| Intervention | 1. Intervention group: postoperative prescribed supplementation (ProCal) and standard diet 2. Control group: standard diet only |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 46 |
| Key inclusion criteria | All consecutive patients undergoing elective colorectal surgery in the Freeman Hospital, Newcastle upon Tyne |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Newcastle upon Tyne Hospitals NHS Foundation Trust
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Newcastle upon Tyne Hospitals NHS Trust
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/10/2017: No publications found, verifying study status with principal investigator.
