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


N/A
18 Years
N/A
Open (Enrolling)
Both
Esophagectomy, Esophageal Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

James D Luketich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UPMC - Heart, Lung, and Esophageal Surgery Institute

Authority:

United States: Institutional Review Board

Study ID:

99-0522

NCT ID:

NCT00260559

Start Date:

May 1999

Completion Date:

Related Keywords:

  • Esophagectomy
  • Esophageal Cancer
  • Esophagectomy
  • Esophageal Cancer
  • Quality of Life
  • Minimally Invasive Esophagectomy
  • Laparoscopic Transhiatal Esophagectomy
  • Open Esophagectomy
  • Karnofsky Score
  • Dysphagia score
  • Heartburn Scale
  • Nutrition Score
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location
University of Pittsburgh Medical Center - Heart, Lung, and Esophageal Surgical Institute Pittsburgh, Pennsylvania  15213
UPMC - Hillman Cancer Center Pittsburgh, Pennsylvania  15232