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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00260559
First received: November 28, 2005
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Esophagectomy
Esophageal Cancer
Procedure: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 1200
Study Start Date: May 1999
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: December 2050 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Questionnaires
    Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260559

Contacts
Contact: Julie A Ward, BSN 412-647-8583 wardj@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center - Heart, Lung, and Esophageal Surgical Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julie A. Ward, BSN    412-647-8583    wardj@upmc.edu   
Principal Investigator: James D. Luketich, MD         
Sub-Investigator: Neil A. Christie, MD         
Sub-Investigator: Rodney J. Landreneau, MD         
Sub-Investigator: Arjun Pennathur, MD         
Sub-Investigator: Ghulam Abbas, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Manisha Shende, MD         
Sub-Investigator: Samuel Keeley, MD         
Sub-Investigator: Lawrence Crist, MD         
Sub-Investigator: Benny Weksler, MD         
Sub-Investigator: Ryan Levy, MD         
Sub-Investigator: Omar Awais, DO         
Sub-Investigator: Katie Nason, MD         
Sub-Investigator: Michael Gibson, MD         
Sub-Investigator: Kevin McGrath, MD         
Sub-Investigator: Angela Gallagher, CRNP         
Sub-Investigator: Jason Lamb, MD         
UPMC - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie A. Ward, BSN    412-647-8583    wardj@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: James D Luketich, MD UPMC - Heart, Lung, and Esophageal Surgery Institute
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00260559     History of Changes
Other Study ID Numbers: 99-0522
Study First Received: November 28, 2005
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Esophagectomy
Esophageal Cancer
Quality of Life
Minimally Invasive Esophagectomy
Laparoscopic Transhiatal Esophagectomy
Open Esophagectomy
Karnofsky Score
Dysphagia score
Heartburn Scale
Nutrition Score

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014