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Gastrointestinal Functional Outcome Ivor Lewis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658837
Recruitment Status : Unknown
Verified January 2019 by University Hospitals, Leicester.
Recruitment status was:  Recruiting
First Posted : September 5, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

Study Description
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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.


Condition or disease Intervention/treatment
Oesophageal Cancer Procedure: Ivor Lewis Oesophagectomy

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Functional Outcome Following Ivor-Lewis Oesophagectomy
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Ivor Lewis Oesophagectomy
    Patients who underwent Ivor-Lewis Oesophagectomy for cancer of oesophagus

Outcome Measures
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Primary Outcome Measures :
  1. Quantitative Assessment using EORTC QLQ-C30 (version 3.0) [ Time Frame: Beyond 12 months up to 5 years ]

    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.


  2. Quantitative Assessment using EORTC QLQ-OES-24 [ Time Frame: Beyond 12 months up to 5 years ]

    EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer.

    Scale scores will be calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems



Secondary Outcome Measures :
  1. Qualitative analysis [ Time Frame: Beyond 12 months up to 5 years ]
    Interviews will be conducted with up to 15 participants and their carers and qualitative analysis of interviews will be performed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658837


Contacts
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Contact: KUMARESAN SUPRAMANIAM, MBBS +44-07415745244 kumaresan80@gmail.com

Locations
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United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Kumaresan Supramaniam, MS       kumar.supramaniam@uhl-tr.nhs.uk   
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
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Study Director: DAVID J BOWREY, MD University Hospitals, Leicester
  Study Documents (Full-Text)

Documents provided by University Hospitals, Leicester:
Study Protocol  [PDF] June 2, 2018

More Information
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Additional Information:

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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03658837    
Other Study ID Numbers: EDGE ID 107692
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No