Investigating the effectiveness of a nutritional intervention to enhance patient recovery after elective major lung surgery

Adults undergoing major lung surgery randomised to nutritional intervention or equivalent volume in water to assess the effects on post-operative outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16535341

Enrollment

Registered

2016-12-19

Start date

2016-09-22

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Cancer, Primary sub-specialty: Lung Cancer

Interventions

After written informed consent, the patient will be randomised, before surgery, to either a nutritional intervention or water. Participants will be individually randomised into the study in an equal 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged over 18 years 2. Undergoing elective major lung surgery (MLS) 3. Able to consume nutritional drinks prior to surgery 4. Able to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Likely inability to comply with completion of the study questionnaires 2. Body mass index (BMI) < 18.5 kg/m2 3. Receiving enteral nutrition 4. Known pregnancy

Design outcomes

Primary

Measure	Time frame
Recruitment rate is recorded as the number of eligible participant who consent to participate in the study by 12 months.	—

Secondary

Measure	Time frame
1. Reasons for failure to recruit are assessed by screening log at the end of the study 2. Ease and efficiency of randomisation process is assessed by speed in which patients can be randomised and whether important prognostic data can be collected pre-operatively at the end of the study 3. Compliance rate of the intervention and contamination rate of the control group is assessed by data gathered by questionnaire and interview, we would expect to have a compliance of 50% of prescribed carbohydrate drinks and ONS taken as scheduled by the end of recruitment 4. Robustness of data collection processes during patient’s hospital stay is assessed by completeness of important peri-operative data to be over 90% for each patient. 5. Follow-up rate of patients at 3 months is assessed by a response rate of 80% at 3 months 6. Reasons for loss of follow-up (if any) are measured at 3 months,100% of mortality data will be captured. 7. Questionnaire best reflects patient experience is assessed by patient interviews at 3-4 week post-surgery. 8. Variability and distribution of quality of life questionnaires measured by return rate up to 3 months after surgery	—

Measure

Time frame

1. Reasons for failure to recruit are assessed by screening log at the end of the study 2. Ease and efficiency of randomisation process is assessed by speed in which patients can be randomised and whether important prognostic data can be collected pre-operatively at the end of the study 3. Compliance rate of the intervention and contamination rate of the control group is assessed by data gathered by questionnaire and interview, we would expect to have a compliance of 50% of prescribed carbohydrate drinks and ONS taken as scheduled by the end of recruitment 4. Robustness of data collection processes during patient’s hospital stay is assessed by completeness of important peri-operative data to be over 90% for each patient. 5. Follow-up rate of patients at 3 months is assessed by a response rate of 80% at 3 months 6. Reasons for loss of follow-up (if any) are measured at 3 months,100% of mortality data will be captured. 7. Questionnaire best reflects patient experience is assessed by patient interviews at 3-4 week post-surgery. 8. Variability and distribution of quality of life questionnaires measured by return rate up to 3 months after surgery

—

Countries

England, United Kingdom

Contacts

Public ContactAmy Kerr

amy.kerr@heartofengland.nhs.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026