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

This study is currently recruiting participants.
Verified by University of Pittsburgh, February 2008

Sponsored by: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00260559
  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

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Heartburn   

U.S. FDA Resources

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

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   600
Study Start Date:   May 1999

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

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: Miguel Alvelo-Rivera, MD            
      Sub-Investigator: Sebastien Gilbert, MD            
      Sub-Investigator: Neil A. Christie, MD            
      Sub-Investigator: Rodney J. Landreneau, MD            
      Sub-Investigator: Arjun Pennathur, MD            
      Sub-Investigator: Ghulam Abbas            
      Sub-Investigator: Matthew Schuchert, MD            
      Sub-Investigator: Brian Pettiford, MD            
      Sub-Investigator: Kevin McGrath, MD            
      Sub-Investigator: Stephanie Land, PhD.            
      Sub-Investigator: Patricia Churilla, CRNP            
      Sub-Investigator: Manisha Shende, MD            
      Sub-Investigator: Angela Gallagher, CRNP            
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

Responsible Party:   University of Pittsburgh ( James Luketich, MD )
Study ID Numbers:   99-0522
First Received:   November 28, 2005
Last Updated:   February 8, 2008
ClinicalTrials.gov Identifier:   NCT00260559
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

Study placed in the following topic categories:
Pyrosis
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Quality of Life
Deglutition Disorders
Digestive System Diseases
Head and Neck Neoplasms
Heartburn
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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