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

University of Pittsburgh

Status: Enrolling

Conditions: Esophageal Cancer; Esophagectomy

Treatments: Procedure: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT00260559

STUDY20040382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.