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 designRandomized; Both; Design type: Prevention, Dietary, Management of Care, Qualitative
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleAdults undergoing major lung surgery randomised to nutritional intervention or equivalent volume in water to assess the effects on post-operative outcomes
Study acronymThIRStY
Study objectivesThe 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) studiedSpecialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs
InterventionAfter 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 typeOther
Primary outcome measureRecruitment rate is recorded as the number of eligible participant who consent to participate in the study by 12 months.
Secondary outcome measures1. 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 date16/06/2016
Completion date21/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 60; UK Sample Size: 60
Total final enrolment64
Key inclusion criteria1. 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 criteria1. 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 enrolment22/09/2016
Date of final enrolment21/09/2017

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 date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThis 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 planThe 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.