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

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:

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

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