Menu
Recruiting NCT00260559

Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

— Observational Esophagectomy Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Esophagectomy, Esophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. To compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (QOL). To look at the applicability of this QOL instrument to this patient group.

Detailed description

Assess short and long term outcomes after minimally invasive esophagectomy(MIE) compared to open esophagectomy. Measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (QOL) using the MOS SF36 questionnaire. Evaluate whether the SF36 will accurately reflect pre and postoperative changes in clinical status in this patient group.Compare the results of this global QOL instrument (SF 36) to disease specific scales of dysphagia and reflux. Assess the impact of adjuvant or neoadjuvant therapy on QOL in this patient group and determine if any advantages of MIE can be demonstrated.

Interventions

  • Procedure Questionnaires
    Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.

Primary outcome measures

  • Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative [Time frame: Baseline and 4 month postoperative]
  • Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative [Time frame: Baseline and 6 month postoperative]
  • Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative [Time frame: Baseline and 12 month postoperative]
  • Change from baseline in SF36 Quality of Life Questionnaire at 18 month [Time frame: Baseline and 18 month postoperative]
  • Change from baseline in SF36 Quality of Life Questionnaire at 24 month [Time frame: Baseline and 24 month postoperative]
  • Change from baseline in SF36 Quality of Life Questionnaire at 30 month [Time frame: Baseline and 30 month postoperative]
  • Change from baseline in SF36 Quality of Life Questionnaire at 36 month [Time frame: Baseline and 36 month postoperative]

Eligibility criteria

Inclusion criteria

  • Patients scheduled for MIE (Minimally Invasive Esophagectomy)
  • Patients scheduled for open esophagectomy
  • Signed informed consent

Exclusion criteria

  • Patients who are unable to comprehend or complete the QOL instruments.
  • Patients less than 18 years of age.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 2 centers
  • University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery — Pittsburgh
  • UPMC - Hillman Cancer Center — Pittsburgh

Identifiers

NCT: NCT00260559 · STUDY20040382

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗