Clinical trial NCT03658837: Gastrointestinal Functional Outcome Ivor Lewis
Official title: Functional Outcome Following Ivor-Lewis Oesophagectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oesophageal Cancer
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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 up to 5 years. 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.

Detailed description: Oesophago-gastric (OG) cancer is the fifth most common malignancy in the United Kingdom, affecting approximately 16,000 people each year. Although surgery offers the best prospect for potential cure of OG cancers, radical treatment may result in increased treatment relate 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 patients quality of life (QOL) is necessary. 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 includes 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. These functional disorder are not always detected immediately post operatively, but may become more troublesome as time goes by.

The purpose of this study is

* to evaluate mid to long term HRQL in patients that underwent Ivor Lewis esophagectomy (ILE) with gastric pull-up in Royal Leicester Infirmary with minimum of 12 months follow up and up to 5 years.
* to 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 The outcome of this study would benefit both surgeons and patients in terms of pre-operative counselling and planning.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent Ivor Lewis Oesophagectomy in Leicester Royal Infirmary with minimum follow up of 12 months.
* Age more than 18

Exclusion Criteria:

* Disease recurrence within the follow up period
* Age less than 18

Primary outcomes:
measure: Quantitative Assessment using EORTC QLQ-C30 (version 3.0)
timeFrame: Beyond 12 months up to 5 years
measure: Quantitative Assessment using EORTC QLQ-OES-24
timeFrame: Beyond 12 months up to 5 years
Secondary outcomes:
measure: Qualitative analysis
timeFrame: Beyond 12 months up to 5 years
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
Study officials:
affiliation: University Hospitals, Leicester
name: DAVID J BOWREY, MD
role: STUDY_DIRECTOR
References: