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
Protocol serial number	N0503191877
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Newcastle upon Tyne Hospitals NHS Foundation Trust

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

Mr Alan Horgan
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Muscle strength at discharge measured using handgrip dynamometry
Key secondary outcome measure(s)	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
Completion date	01/10/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Freeman Hospital

Newcastle upon Tyne
NE7 7DN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

12/10/2017: No publications found, verifying study status with principal investigator.