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

ISRCTN	ISRCTN16535341
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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-carbohydrate-drinks-after-lung-surgery-to-improve-recovery-thirsty

Contact information

Mrs Amy Kerr
Public

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United Kingdom

Email	amy.kerr@heartofengland.nhs.uk

Study information

Study design	Randomized; Both; Design type: Prevention, Dietary, Management of Care, Qualitative
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
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

Sponsor information

Heart of England NHS Foundation Trust
Hospital/treatment centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
England
United Kingdom

Email	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
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?
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.