NCT00260559

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,500 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagectomy
• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	Questionnaires	Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.

Timeline

• Start date: 1999-05-01
• Primary completion: 2050-12-01
• Completion: 2050-12-01
• First posted: 2005-12-01
• Last updated: 2026-04-14

Locations

2 sites across 1 country: United States