Gastrointestinal Functional Outcome Ivor Lewis

NCT03658837 | Completed DMC

• 1 other identifier: EDGE ID 107692
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Cancer

Outcome Measures

Primary Outcomes (2)

• Quantitative Assessment using EORTC QLQ-C30 (version 3.0)

  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.

  Beyond 12 months up to 5 years

• Quantitative Assessment using EORTC QLQ-OES-24

  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

  Beyond 12 months up to 5 years

Secondary Outcomes (1)

• Qualitative analysis

  Beyond 12 months up to 5 years

Interventions

Ivor Lewis Oesophagectomy PROCEDURE

Patients who underwent Ivor-Lewis Oesophagectomy for cancer of oesophagus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• DAVID J BOWREY, MD

  University Hospitals, Leicester

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: September 5, 2018
• Study Start: January 3, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)