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

Tracking Information

First Received Date ^ICMJE

November 28, 2005

Last Updated Date

October 13, 2008

Start Date ^ICMJE

May 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00260559 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Esophagectomy
Esophageal Cancer

Intervention ^ICMJE

Procedure: Questionnaires

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Julie A Ward, BSN

412-647-8583

wardj@upmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00260559

Responsible Party

James Luketich, MD, University of Pittsburgh

Study ID Numbers ^ICMJE

99-0522

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

James D Luketich, MD

UPMC - Heart, Lung, and Esophageal Surgery Institute

Information Provided By

University of Pittsburgh

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP