Investigating the effectiveness of a nutritional intervention to enhance patient recovery after elective major lung surgery
ISRCTN | ISRCTN16535341 |
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DOI | https://doi.org/10.1186/ISRCTN16535341 |
Secondary identifying numbers | CPMS 31591 |
- Submission date
- 28/11/2016
- Registration date
- 19/12/2016
- Last edited
- 10/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mrs Amy Kerr
Public
Public
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-
-
United Kingdom
amy.kerr@heartofengland.nhs.uk |
Study information
Study design | Randomized; Both; Design type: Prevention, Dietary, Management of Care, Qualitative |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Adults undergoing major lung surgery randomised to nutritional intervention or equivalent volume in water to assess the effects on post-operative outcomes |
Study acronym | ThIRStY |
Study objectives | The aim of this study is to assess the feasibility of carrying out a randomised controlled trial comparing the effectiveness of a nutritional intervention (NI) of preoperative carbohydrate-loading drinks and early postoperative nutritional supplement drinks compared to receiving an equivalent volume of water in enhancing recovery after major lung surgery (MLS) |
Ethics approval(s) | Wales REC 7, 05/09/2016, ref: 16/WA/0254 |
Health condition(s) or problem(s) studied | Specialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs |
Intervention | 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 1:1 ratio. Randomisation will be by a web based randomisation system. Patients will be stratified by diagnosis (cancer or benign) and type of surgery (key hole or open). The nutritional intervention in brief the evening before surgery 4x200mls, the morning of surgery, 2X200mls of carbohydrate-loading supplement will be given. In the postoperative period patients will be given 125ml polymeric nutritional supplement drink twice a day from the period immediately after their operation for 2 weeks. The control group will consume the same quantity of water thus any benefit from the intervention will not be due to preventing dehydration. Follow up will be 3 months post-surgery with Visual Analogue Score (VAS), Quality of Recovery and EQ5D questionnaires. |
Intervention type | Other |
Primary outcome measure | Recruitment rate is recorded as the number of eligible participant who consent to participate in the study by 12 months. |
Secondary outcome measures | 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 |
Overall study start date | 16/06/2016 |
Completion date | 21/12/2017 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
Total final enrolment | 64 |
Key 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 |
Key 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 |
Date of first enrolment | 22/09/2016 |
Date of final enrolment | 21/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Heartlands Hospital
Bordsley green
Birmingham
B9 5SS
United Kingdom
Birmingham
B9 5SS
United Kingdom
Sponsor information
Heart of England NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
England
United Kingdom
1@1 |
Funders
Funder type
Hospital/treatment centre
Heart of England NHS Foundation Trust
No information available
Results and Publications
Intention to publish date | 31/12/2018 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | This feasibility study is designed to identify if a substantive trial is possible. Although a definitive answer to the key research question on effectiveness of nutritional intervention in patient undergoing major thoracic surgery cannot be provided, the findings of this feasibility study will be of scientific interest to others in their own right. The dissemination strategy has been planned in three aspects. The first will ensure that patients and health professionals are informed of the feasibility findings; the second will engage multi-disciplinary professionals to support a proposal of a definitive RCT and the third will be to submit a grant application dependant on the success of the feasibility study (2018). |
IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Preprint results | non-peer-reviewed results | 13/09/2021 | 21/09/2021 | No | No |
Results article | 28/06/2022 | 30/06/2022 | Yes | No | |
HRA research summary | 28/06/2023 | No | No | ||
Plain English results | 10/10/2024 | No | Yes |
Editorial Notes
10/10/2024: Cancer Research UK plain English results link added.
30/06/2022: Publication reference added.
21/09/2021: The following changes have been made:
1. Preprint reference added.
2. The total final enrolment number has been added from the reference.
16/03/2017 Cancer Help UK lay summary link added.