Reduction of surgical stress by prevention of perioperative starvation
| ISRCTN | ISRCTN89225485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89225485 |
| Protocol serial number | N0185146353 |
| Sponsor | Department of Health |
| Funders | Plymouth Hospitals NHS Trust, NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 28/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Lewis
Scientific
Scientific
level 09
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Does feeding surgical patients improve intestinal permeability and insulin resistance? The purpose of this study is to examine the effect of maintaining patients nutritional intake in the pre and postoperative period on insulin resistance, nitrogen turnover and intestinal permeability. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery |
| Intervention | The day before the operation study patients will be encouraged to take clear liquid dietary supplements during the day before their operation and on the day of their operation. Patients in group A will receive a placebo supplement of flavoured water. Patients in groups B and C will receive Fortisip. The amount of supplements will be measured to meet the patients calculated daily energy requirement. On the operative day patients will take 200ml of supplement drink at 8am then another 200ml 4 hours before their operations. In the postoperative period patient will be encouraged to take the liquid supplements as tolerated from the period immediately after their operation until normal diet is resumed. Patients in groups A and B will receive placebo supplement drinks whilst those in group C will receive Fortijuice. Insulin resistance will be measured using the HOMA method and by using a short insulin tolerance test. Intestinal permeability will be measured using a duel sugar test. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 09/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 60 participants in total - 40 experimental group, 20 control. |
| Key exclusion criteria | <18 years, diabetic, pregnant or lactating, receiving tube delivered nutrition, participating in another study. |
| Date of first enrolment | 12/09/2002 |
| Date of final enrolment | 09/02/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
level 09
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
