Contact information
Type
Public
Primary contact
Mrs Amy Kerr
ORCID ID
Contact details
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United Kingdom
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amy.kerr@heartofengland.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31591
Study information
Scientific title
Adults undergoing major lung surgery randomised to nutritional intervention or equivalent volume in water to assess the effects on post-operative outcomes
Acronym
ThIRStY
Study hypothesis
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
WALES REC 7, 05/09/2016, ref: 16/WA/0254
Study design
Randomised; Both; Design type: Prevention, Dietary, Management of Care, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
16/06/2016
Overall trial end date
21/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients, aged over 18
2. Undergoing elective major lung surgery (MLS)
3. Able to consume nutritional drinks prior to surgery
4. Able to give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant 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
Recruitment start date
22/09/2016
Recruitment end date
21/09/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Heartlands Hospital
Bordsley green
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Heart of England NHS Foundation Trust
Sponsor details
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
United Kingdom
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1@1
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Heart of England NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
31/12/2018
Participant level data
Other
Results - basic reporting
Publication summary