Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Conditions
Esophagectomy - Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophagectomy, Esophageal Cancer, Quality of Life, Minimally Invasive Esophagectomy, Laparoscopic Transhiatal Esophagectomy, Open Esophagectomy, Karnofsky Score, Dysphagia score, Heartburn Scale, Nutrition Score
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Questionnaires
Type: Procedure
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
University of Pittsburgh Medical Center - Heart, Lung, and Esophageal Surgical Institute
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Julie A. Ward, BSN - 412-647-8583 - wardj@upmc.edu
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Julie A. Ward, BSN - 412-647-8583 - wardj@upmc.edu
Start Date
May 1999
Completion Date
December 2050
Sponsors
University of Pittsburgh
Source
University of Pittsburgh
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page