Functional Outcome Following Ivor-Lewis Oesophagectomy
Conditions: Oesophageal Cancer
Sponsor: University Hospitals, Leicester

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FULL/LONG TITLE OF THE STUDY 
 
Functional Outcome following Ivor-Lewis Oesophagectomy 
 
SHORT STUDY TITLE / ACRONYM 
 
Functional Outcome Ivor Lewis 
 
PROTOCOL VERSION NUMBER AND DATE 
 
Version 2 
 
Date 02/06/2018 
 
RESEARCH REFERENCE NUMBERS 
IRAS Number: 240683 
 
SPONSORS Number: EDGE ID 107692 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name: 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
....../....../...... 
Name: KUMARESAN SUPRAMANIAM 
.................................................................................................... 
 
 
 
 
 
 
 
 
 
 

 
 
 
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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
HRA PROTOCOL COMPLIANCE DECLARATION  
i 
TITLE PAGE  
ii 
RESEARCH REFERENCE NUMBERS 
 
ii 
SIGNATURE PAGE 
iii 
LIST OF CONTENTS  
iv 
KEY STUDY CONTACTS 
v 
STUDY SUMMARY 
vi 
STUDY FLOW CHART 
 
vii 
SECTION  
1. BACKGROUND 
 
1 
2. RATIONALE 
 
4 
3. THEORETICAL FRAMEWORK 
4 
4. RESEARCH QUESTION/AIM(S)  
5 
5. STUDY DESIGN/METHODS 
6 
6. STUDY SETTING 
8 
7. SAMPLE AND RECRUITMENT 
10 
8. ETHICAL AND REGULATORY COMPLIANCE 
12 
9. DISSEMINATION  POLICY 
16 
10. REFERENCES 
17 
11. APPENDICES 
20 
 
 

 
 
 
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KEY STUDY CONTACTS 
 
Chief Investigator 
Mr Kumaresan Supramaniam 
Upper GI International Training Fellow, University Hospitals of 
Leicester NHS Trust 
Telephone : +44 074157452443 
Email : kumar.supramaniam@uhl-tr.nhs.uk 
Study Co-ordinator 
Mr David Bowrey,  
Consultant General/Upper GI Surgeon, University Hospitals 
of Leicester NHS Trust 
Telephone : 0116 258 5427 
Email : david.j.bowrey@uhl-tr.nhs.uk 
Sponsor 
Carolyn Maloney PGDip(ResEth) 
Head of Research Operations 
University Hospitals of Leicester NHS Trust 
Research & Innovation, Leicester General Hospital,  
Gwendolen Road, Leicester, LE5 4PW. 
Tel: +44 116 258 4109 
Mob: +44 7903 877501 
Email : UHLSponsor@uhl-tr.nhs.uk 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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STUDY SUMMARY 
 
Study Title 
Functional Outcome Following Ivor Lewis Oesophagectomy 
Internal ref. no. (or short title) 
Functional Outcome Ivor Lewis 
Study Design 
A. Quality of life Questionnaires 
B. Qualitative Semi-structured Interviews 
Study Participants 
Patients who underwent Ivor Lewis Oesophagectomy with 
minimum follow up of 12 months at Leicester Royal Infirmary 
Planned Size of Sample (if applicable) Part A: 100 patients 
Part B: 15 patients 
Follow up duration (if applicable) 
NA 
Planned Study Period 
Study Recruitment Period  – 12 months 
Research Question/Aim(s) 
 
To 
-Evaluate midterm Quality of Life in patients that underwent 
Ivor Lewis Oesophagectomy with gastric pull-up   
-Identify clinical factors influencing quality of life post 
operatively 
-Explore patients’ experiences of their quality of life and how 
they handle their new life situation from a long-term 
perspective after oesophagectomy 
 
 
 
 
KEY WORDS: 
Functional Outcome, Ivor Lewis Oesophagectomy, 
Quantitative, Qualitative 
 
 
 
 
 
 
 
 
 
 

 
 
 
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STUDY FLOW CHART 
 
 
 
 
 
 
•Patients Selection 
Patients with diagnosis of 
Oesophageal/Oesophageal-
Gastric Cancer who underwent 
Ivor Lewis Oesophagectomy with 
gastric pull up, with minimum 
follow up of 12 months at 
Leicester Royal Infirmary 
 
•Distribution of Patient 
Information Sheet, Reply Slip  
and EORTC Questionnaires 
 
•Collection of  Reply Slip and  
Process of Obtaining Consent 
 
•Selected Individuals  for 
Qualitative Assessment 
 
•Data Collection and Analysis 

 
 
 
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STUDY PROTOCOL 
Functional Outcome Following Ivor Lewis Oesophagectomy 
 
1 
BACKGROUND 
Oesophago-gastric (OG) cancer is the fifth most common malignancy in the United Kingdom, affecting 
approximately 16,000 people each year. The prognosis for most patients with these cancers is poor as 
they typically experience symptoms when the disease has become fairly advanced. Five-year survival 
rates for oesophageal and gastric cancer are 15 percent and 19 percent respectively. (1,2) 
The figures from Office of National Statistics (ONS) pertaining to net survival estimates for 
oesophageal cancer in England are 42.3 percent for one year and 14.2 percent for five years, which 
compares unfavourably too many other types of cancer. (3)  
Surgery is the mainstay of curative treatment for patients with localized disease, and is often 
combined with neoadjuvant chemotherapy and/or radiotherapy. Curative surgery for OG cancer is a 
major undertaking, even in a high volume centres, and is only suitable for patients who are relatively 
fit. Only, approximately 30 percent of patients are candidates for a treatment with curative intent with 
the remainder either presenting with advanced disease or being judged unfit for the radical treatments 
required for cure. (1) 
Although surgery offers the best prospect for potential cure of OG cancers, radical treatment may 
result in increased treatment related mortality, high treatment-induced morbidity, and reduced quality 
of life. Traditionally, many centres managing OG cancers focused on mortality and morbidity as their 
key outcome measures. However, a growing body of opinion considers that a measure of broader 
effects of ill health and treatment on the patient’s quality of life (QOL) is necessary. (4,5). Such 
considerations are important, as it is questionable if patients are subjected to treatment merely to offer 
them a few extra months of life, particularly if this is at the expense of quality of life. These include 
physical, functional, social and physiological aspects of life. 
More than half of the operated patients will develop significant functional disorder after surgery 
affecting QOL. The most common problems observed are dysphagia, dumping syndrome, delayed 
gastric emptying, and reflux. (6) These functional disorders are not always detected immediately post 
operatively, but may become more troublesome as time goes by. (7) 
 

 
 
 
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A frequent gastrointestinal symptom following surgery for oesophageal cancer is dysphagia which has 
an estimated incidence of between 21 to 56%, and interestingly is similar following definitive 
chemoradiation therapy. (26, 27) Several studies have identified risk factors for developing post-
surgical, non-malignant, strictures which could lead to significant dysphagia including tension on the 
anastomosis, insufficient blood supply, radiotherapy, chemotherapy, anastomotic leak and fistula, 
reflux and intra or post operative hypotension. Systemic disorders such as diabetes mellitus and 
cardiovascular disease also been identified as risk factors. (6,8,9) 
Delayed gastric emptying is also a significant problem following oesophagectomy. This occurs 
because of the gastric tubulisation, which reduces the function as a reservoir, and compounded by 
alteration in hormonal reflexes and vagotomy. Stasis of gastric acid could potentially lead to 
anastomotic stricture. Early satiety and postprandial discomfort are the two most common symptoms 
of delayed gastric emptying. Patients are generally advised to consume small frequent meals, up to 
five or six times a day, followed by fluid intake. To date, no surgical procedure has been clearly 
demonstrated to be effective for the prevention of delayed gastric emptying. Nine randomised trials 
were analysed in a meta-analysis regarding pyloroplasty, which found a lower rate of early post 
operative gastric obstruction after pyloroplasty but no difference for the quality of gastric emptying at 
mid and long term. It also could lead to biliary reflux and dumping syndrome. Contradictary results 
have been reported concerning the influence of the size of gastroplasty and the use of vagal-sparing 
oesophagectomy. (6)  
Another common functional problem is reflux. Up to 80% of patients present with symptoms related 
with acid or bilio-pancreatic reflux. (21,22) Oesophagitis has been reported in 38 to 76% of patients 
(23) and supra-anastomotic Barrett’s metaplasia in 8 to 50%. (24,25) Loss of the anti-reflux 
mechanism and the exposure of gastric tube to the negative intra thoracic pressure increase chances 
of developing significant reflux post operatively. Patients would usually present with burning 
sensations in upper chest and neck worsened by lying in prone position especially at night. This 
subsequently leads to poor sleep and nocturnal cough. (6) Multiple variation in creating the 
anastomosis has been studied in an attempt to reduce incidence of post operative reflux, including; 
formation of a neck anastomosis rather than thoracic anastomosis; retrosternal gastroplasty; 
pyloroplasty; and creation of peri-anastomotic valve. Nevertheless, these different techniques are not 
used in routine surgical practice with most surgeons preferring to avoid a more complex surgery. 
 

 
 
 
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Significant gastrointestinal symptoms are associated with dumping syndrome which is relatively 
common consequence of oesophagectomy with a reported prevalence of between 10 to 50%. The 
pathophysiology of dumping syndrome is complex but includes rapid transit of a hypersomolar bolus 
into the jejunum leading to splanchic vasodilatation and systemic hypotension due to relative 
hypovolemia. The hyperosmolarity also triggers excessive secretion of various peptides which leads to 
diarrhoea and inhibition of water and sodium absorption. Symptoms include palpitations, nausea, 
diaphoresis, flushes, diarrhoea and abdominal cramps. Late dumping can also occur with symptoms 
of trembling, somnolence and concentration disorder. Small group of patients can present with both 
accelerated and delayed dumping syndrome. (6) 
It is recognised that only a small number of patients are asymptomatic in the long term (10,11) and 
that the occurrence of functional disorders and postoperative complications has an influence on QOL. 
Previous studies have shown that the lowest level of QOL occurs at approximately four to six weeks 
postoperatively. (12,13) Almost 50 percent of the patients have at least one functional disorder within 
the first month following surgery. (14) Most functional recovery takes place during the first two years 
after surgery with concurrent improvement in QOL. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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2 
RATIONALE  
Much of the focus for the treatment of oesophageal cancer is based on cancer clearance, peri-
operative morbidity and mortality. Treatment frequently consists of chemotherapy and or radiotherapy 
followed by a complex major operation consisting of surgery performed both in the abdomen and 
thorax. Cancer registries have rightly focused on measuring mortality and morbidity for these patients 
and considerable improvements in these outcomes has been evident of the years. With improvements 
in oesophagectomy outcomes patients may be left with long-term consequences of their treatment, 
experiencing unpleasant gastrointestinal symptoms that may have a prolonged deleterious effect on 
their QOL. Much of the qualitative research to date has focused on recovery in the first two years 
post-op.  
 
3 
THEORETICAL FRAMEWORK 
This study focuses on the prevalence of functional complications and their impact on QOL in patients 
who underwent an Ivor Lewis Oesophagectomy. 
This study will assess the prevalence of gastrointestinal symptoms and QOL from beyond the first 
year following surgery. The aim is to determine whether gastrointestinal side effects and QOL are 
compromised in the long-term.  
This study will also explore in details, the impact of surgery on their quality of life and gastro intestinal 
symptoms that patients has experienced post operatively.  
 
 
 
 
 
 
 
 
 

 
 
 
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4 
RESEARCH QUESTION/AIM(S) 
 
To assess quality of life following Ivor Lewis Oesophagectomy with a minimum of 1 year follow up 
To explore patient’s personal experience of their quality of life and how they handle their new life 
situation from a long-term perspective after oesophagectomy 
 
 
4.1 
Objectives 
 
The purpose of this study is  
-To evaluate mid to long term HRQL in patients that underwent Ivor Lewis Oesophagectomy with 
gastric pull-up   
-To identify clinical factors influencing quality of life post operatively. 
-To explore patients perspective on changes that they have experienced post operatively focusing on 
quality of life and gastro intestinal symptoms. 
 
4.2 
Outcome 
Quality of life based on EORTC questionnaires 
Qualitative semi-structured interviews 
 
 
 
 
 
 
 
 
 

 
 
 
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STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS 
PART A: QUALITY OF LIFE QUESTIONNAIRES 
Subjects will be recruited through existing Upper GI Cancer Database following which identified 
patients will receive invitation letter, patient information leaflet and reply slip. Interested cohort of 
patients will be approached for obtaining consent and distribution of stamped addressed envelope 
containing questionnaires. This process will be done from 1st Sept 2018 up to 31st Aug 2019. 
Quality of life will be evaluated using the validated EORTC core questionnaire (QLC C-30, OES-18). 
The combination of QLQ-C30 and QLQ-OES18 is considered to precisely reflect the changes in the 
quality of life of oesophageal cancer patients and is recommended by EORTC to evaluate the quality 
of life of such patients. 
EORTC QLQ-C30 (version 3.0) is a self-assessment questionnaire describing 5 functional indices, 
including physical, role, cognitive, emotional and social functions, 3 symptom indices, including 
fatigue, pain and nausea or vomiting and 1 general score. EORTC QLQ-OES18 includes 18 indices, 
namely specific symptoms, such as dysphagia and oesophageal reflux. (15,16) 
Descriptive analysis of all the demographic, clinical and outcome variables will be performed. Results 
of the continuous variables will be described in mean and standard deviation for normally distributed 
data and median and inter-quartile range for non-normally distributed data. Results of categorical 
variables will be described in frequency and percentage. Test of Normality will be used to determine 
the distribution of the outcome variables.  
Correlation between the subscales will be determined using Pearson (for normally distributed) or 
Spearman (for non-normally distributed) Correlation, with the corresponding Correlation Coefficient 
and p values reported. To identify demographic and clinical factors associated with functional, 
symptom and global health status outcome, univariate and multivariate linear regression analysis will 
be used. 
 
 
 
 
 

 
 
 
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PART B: QUALITATIVE EXPLORATORY STUDY 
Potential participants for part B will be those recruited into EORTC QOL assessment study. At the 
initial recruitment stage, participants will be asked to indicate on the consent form if they agree to be 
interviewed. Purposeful sampling will be adopted to ensure appropriate selection of cases. On 
agreement, consent will be taken prior to interview taking place. It is anticipated that no more than 15 
patients will be included. 
The interviews will all follow the same semi-structured format. The interview schedule (APPENDIX 3) 
has been developed and encourages exploration and discussion of the following areas: 
- evaluate changes over time, and factors that may impact patients’ quality of life the first year after 
oesophagectomy for cancer  
- illuminate patients’ experiences of their quality of life and how they handle their new life situation 
from a long-term perspective after oesophagectomy for cancer 
Interviews will be conducted in a private room with estimated duration approximately 90 minutes. 
Following each interview, the researcher will make field notes including any observations. This will 
help to inform reflexive reflection. The interview will be digitally recorded and then transcribed 
verbatim. Each participant will be assigned a false name when the interview transcribed, and the 
recording will be destroyed when no longer needed for study purposes. Data organisation and retrieval 
will be managed using the qualitative software package NVivo. 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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6 
STUDY SETTING 
PART A: QUALITY OF LIFE QUESTIONNAIRES 
 
Patient who underwent Ivor Lewis oesophagectomy with lymphadenectomy for oesophageal cancer 
will be selected from our database at the Department of Surgery, Leicester Royal Infirmary. These 
include patients from Leicestershire and Northamptonshire treated at the Leicester Royal Infirmary. 
Mid to long term survivors operated in our institution with a follow up of at least 12 months will be 
identified from our database to be included in our study. Personalised invitation letter together with 
patient information leaflet and reply slip will be posted to all eligible patients. Group of patients who 
express their interest in participating in the study by submitting reply slip will be approached 
individually during their routine clinic follow up or cancer support group meeting. They will be 
consented for both participation and access to their medical records from the disease registers 
ensuring confidentiality. Each patient will be provided with both sets of questionnaires (QLC C-30, 
OES-18) to be completed. Patients will have a choice of returning the completed questionnaires during 
the meeting itself or they could choose to post it back on a later date. Complete demographic data, 
staging of disease, type of treatment received and postoperative complications will be recorded on a 
structured proforma.  
In creating the database with the participant's scores from the questionnaires, each individual will be 
assigned a number to anonymise their data. Hard copies of questionnaires will be kept in a locked 
cabinet at the University Hospitals of Leicester. These questionnaires will be kept securely for five 
years post study and all information held electronically will be password protected. Only the Chief 
Investigator will have access to the electronic database. Participants are free to withdraw consent and 
terminate the study at any point.   
If participants are lost to follow-up / non-compliant, every attempt will be made to contact them, and 
these will be documented. Any reason for withdrawal will be documented on the appropriate CRF 
form. 
Confidentiality and record keeping will be explained to participants within the participant information 
sheet. 
 
 
 
 
 

 
 
 
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PART B: QUALITATIVE EXPLORATORY STUDY 
Qualitative approach of thematic analysis will be used for this study. The conceptual framework of the 
thematic analysis was mainly built upon the theoretical positions of Braun and Clarke (28). According 
to them, thematic analysis can be used for ‘identifying, analysing, and reporting patterns (themes) 
within the data and can produce an insightful analysis that answers particular research questions.  
A theme is something that captures the key idea about the data in relation to the research question 
and which represents some level of patterned response or meaning within the data set.  
Six phase guide provided by Braun and Clarke will be used as a framework in conducting and 
analysing this part of the study 
Step 1: Become familiar with the data 
Step 2: Generate initial codes 
Step 3: Search for themes  
Step 4: Review themes 
Step 5: Define themes 
Step 6: Write-up  
Questions will be semi-structured and adapted on individual basis to cover themes that might emerge 
out of discussions.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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7 
SAMPLE AND RECRUITMENT 
7.1  
Eligibility Criteria 
7.1.1 Inclusion criteria 
Patients who underwent Ivor Lewis Oesophagectomy in Leicester Royal Infirmary with minimum follow up 
of 12 months. 
Age more than 18 
 
7.1.2 Exclusion criteria 
Disease recurrence within the follow up period 
Age less than 18 
 
7.2  
Sampling 
 
7.2.1  Size of sample 
PART A: QUALITY OF LIFE QUESTIONNAIRES 
Based on literature reviews, most functional recovery takes place during the first two years after surgery 
along with improvement in QOL. Study is designed to include every patient with minimum follow up of 
12months, estimated to be approximately 100 patients. 
PART B: QUALITATIVE EXPLORATORY STUDY 
It is anticipated that no more than 15 patients will be included 
 
7.2.2  Sampling technique 
Subjects will be recruited through existing Upper GI Cancer Database following which identified patients 
will receive invitation letter, patient information leaflet and reply slip. Interested cohort of patients will be 
approached for obtaining consent and distribution of stamped addressed envelope containing 
questionnaires. 
 

 
 
 
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7.3 
Recruitment 
7.3.1 Sample identification 
PART A: QUALITY OF LIFE QUESTIONNAIRES 
All eligible patients will be identified through our pre-existing Upper GI Cancer Database at Leicester 
Royal Infirmary. This process will be done by chief investigator and collaborator. 
Agreeable patients will be approached during upcoming clinic follow up or support group meeting.  
PART B: QUALITATIVE EXPLORATORY STUDY 
Potential participants will be those recruited into the Part A of the study. At the initial recruitment stage 
participants will be asked to indicate on the consent form if they agree to be interviewed. Purposeful 
sampling will be adopted to ensure an appropriate selection of cases. 
 
 
7.3.2 Consent 
The nature and objectives of the study and possible risks associated with their participation will be 
discussed between chief investigator/supervisor and potential participant. Patient information leaflet 
and written consent forms will be provided to each potential participant. Patients also will be provided 
time and opportunity to consider decision and to ask further questions. Only when written informed 
consent has been obtained including access to their medical records from the patient can they be 
considered a trial participant.    
 
 
 
 
 
 
 
 

 
 
 
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8 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
8.1 
Assessment and management of risk 
Whilst it is not anticipated that any harm should come to those participating in the study, it is 
acknowledged that there is a possibility that individuals may become upset whilst completing the 
questionnaires. This will be taken into consideration when explaining the research and debriefing. 
Participants will be made aware verbally and via the participant information sheet that the 
questionnaires may ask upsetting questions.  
Taking into consideration the potential risks, it was felt that the benefits justified the potential burden to 
the participants.  
Due to the sensitive nature of the all participants, they will be made aware that their decision to take 
part in this research will not affect the care they receive or will receive in future. When suitable 
individuals have been identified for recruitment to the study, the Chief Investigator will obtain full 
informed consent in writing. Records detailing the date, time and by whom consent was obtained from 
will be kept. Furthermore, emphasis will be placed on the anonymity of the questionnaire responses 
highlighting that only the Chief Investigator will have access to identifiable information and this won’t 
be accessible to the medical team on site. 
Information sheets detailing the research aims and rationale will be given to each potential participant. 
Participants will be made aware of their right to withdraw from the study at any time and emphasis will 
be placed that this will not affect their future care. The Chief Investigator will comply with any requests 
of withdrawal by removing individuals’ data from the database and destroying the questionnaires in an 
appropriate manner that complies with data protection legislation. 
Person-identifiable information of the data set will be integral to the research as it will form the basis of 
comparison across groups for demographic features. It will however be kept in a separate password 
protected document only accessible to the Chief Investigator. On inputting of the data, participants’ 
data will be anonymised by the use of identification numbers. 
Electronic databases containing the information will have restricted access and be password 
protected. 

 
 
 
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Participants will be given the chance to ask questions following the data collection and offered the 
opportunity to receive a lay summary of the key research findings. 
 
8.2 
Research Ethics Committee (REC) and other Regulatory review& reports 
Before the start of the study, a favourable opinion will be sought from UK Health Departments 
Research Ethics Service NHSREC for the study protocol, informed consent forms and other relevant 
documents e.g. advertisements. 
 
Regulatory Review & Compliance  
Before any enrolment into the study takes place, the Chief Investigator/Principal Investigator will 
ensure that appropriate approvals from participating organisations are in place. Specific arrangements 
on how to gain approval from participating organisations are in place and comply with the relevant 
guidance.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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8.3 
Peer review 
This study protocol has been reviewed by 2 Upper Gastrointestinal Consultant who is not involved 
directly in this project. 
 
8.4 
Patient & Public Involvement 
Patients will be actively involved as they will provide current status of their function and quality of life 
guided by the questionnaires provided. Following data analysis and completion of final report, participants 
as well as the public will be able to access the outcome of the study. 
 
 

 
 
 
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8.5 
Protocol compliance  
The current study has been reviewed through the internal peer review process within the Department of 
Surgery of University Hospitals of Leicester. 
The Chief Investigator will receive ongoing supervision from the Academic Supervisor. 
The University Hospitals of Leicester NHS Trust, as Sponsor, operates a risk based monitoring and audit 
programme, to which this study will be subject. 
 
8.6 
Data protection and patient confidentiality  
Demographic information will be stored securely and anonymised on an electronic database. All data will 
be identifiable using a unique participant number allocated to each participant and only the Chief 
Investigator will have access to the demographic information. 
Hard copies of the questionnaires will be kept in a secure storage cabinet at the Department of Surgery of 
University Hospitals of Leicester. 
Electronic databases will have restricted access, be password protected and contain no personal 
information. A participant information sheet will outline details of confidentiality employed in the research 
process. 
Participants will be given the chance to ask questions on completion of the questionnaires and will be 
offered the opportunity to receive a lay summary of the key research findings. 
 
 
 
 
 
 
 
 
 
 

 
 
 
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8.7 
Indemnity 
NHS indemnity will apply as the study sponsor 
 
8.8 
Access to the final study dataset 
After analysis, data will be securely stored at the University Hospitals of Leicester for five years after 
the date of submission and will be accessible by chief investigator and study supervisor. After this 
period, data will be appropriately destroyed. 
9 
DISSEMINIATION POLICY 
9.1  
Dissemination policy 
Upon completion of the data collection and data analysis, a Final Study Report will be prepared and will 
be considered for presentation/publications. Information will be given to the patients on how to ask for a 
copy of the results. A patient friendly lay summary of the research will be produced and made available to 
participants if they wish. 
 
9.2  
Authorship eligibility guidelines and any intended use of professional writers 
Authorship on the final study report will be granted to chief investigator and study supervisor 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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10 
REFERENCES 
 
1. Cancer Research UK Statistical Information. Oesophageal Cancer Statistics. 2015 
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2. Cancer Research UK Statistical Information. Gastric Cancer Statistics. 2015 [Accessed 
Sept 
2015]; 
Available 
from: 
www.cancerresearchuk.org/cancer-info/cancerstats/ 
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3. Office for National Statistics. Cancer Survival in England- Adults Diagnosed: 2009 to 2013, 
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4. Fitzpatrick R, Fletcher A, Gore S, Jones D, Spiegelhalter D, Cox D. Quality of life measures 
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6. Poghosyan T, Gaujoux S, Chirica M, Munoz-Bongrand N, Sarfati E, Cattan P. Functional 
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8. Park JY, Song HY, Kim JH, Park JH, Na HK, Kim YH, et al. Benign anastomotic strictures 
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9. Lerut T, Coosemans W, Decker G, De Leyn P, Nafteux P, van Raemdonck D. Anastomotic 
complications after esophagectomy. Digestive surgery. 2002;19(2):92-8  
10. Deschamps C, Nichols FC, 3rd, Cassivi SD, Allen MS, Pairolero PC. Long-term function 
and quality of life after esophageal resection for cancer and Barrett's. The Surgical clinics 
of North America. 2005; 85(3):649-56, xi.  
11. McLarty AJ, Deschamps C, Trastek VF, Allen MS, Pairolero PC, Harmsen WS. Esophageal 
resection for cancer of the esophagus: long-term function and quality of life. The Annals of 
thoracic surgery. 1997; 63(6):1568-72.  

 
 
 
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12. Djarv T, Lagergren J, Blazeby JM, Lagergren P. Long-term health-related quality of life 
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20. Djarv T, Lagergren J, Blazeby JM, Lagergren P. Long-term health-related quality of life 
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11.  
APPENDICIES 
 
11.1 
Appendix 1- QLQ-C30  
11.2     Appendix 2 - QLQ-OES18 
11.3  Appendix 3 – Semi-structured interview schedule 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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APPENDIX 1 

 
 
 
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APPENDIX 2 

 
 
 
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APPENDIX 3 
 
SEMI STRUCTURED INTERVIEW SCHEDULE 
 
 
Introduction, explanation about proceedings and consent 
 
In general, tell me about how your life has been since your operation. 
Can you tell me how you feel about oesophageal cancer and the impact on your life so far? 
Post operatively, have your symptoms changed with time? Have they got worse, more frequent? Have 
new symptoms come on, that weren’t there to start with? Would you mind telling me more about 
them? 
What is the main changes/adaptation in your daily activity that you have had to make following 
surgery? 
Can you describe any changes to your life that have happened as a consequence of having the 
surgery  E.g. daily routine, social activities, relationships, quality of life. 
How is your appetite, eating and drinking compared to before the operation? 
Is there anything else that you would like to discuss, relating to your experience of the JEJ feeding 
tube, your appetite and food intake that you feel is important? 
To facilitate open discussion,  
Can you tell me more? 
Can you expand on that? 
Can you explain what you mean?