Clinical trial NCT00260559: Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Official title: Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagectomy
Esophageal Cancer
Keywords: Esophagectomy
Esophageal Cancer
Quality of Life
Minimally Invasive Esophagectomy
Laparoscopic Transhiatal Esophagectomy
Open Esophagectomy
Karnofsky Score
Dysphagia score
Heartburn Scale
Nutrition Score
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-12-01
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative
timeFrame: Baseline and 4 month postoperative
measure: Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative
timeFrame: Baseline and 6 month postoperative
measure: Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative
timeFrame: Baseline and 12 month postoperative
measure: Change from baseline in SF36 Quality of Life Questionnaire at 18 month
timeFrame: Baseline and 18 month postoperative
measure: Change from baseline in SF36 Quality of Life Questionnaire at 24 month
timeFrame: Baseline and 24 month postoperative
measure: Change from baseline in SF36 Quality of Life Questionnaire at 30 month
timeFrame: Baseline and 30 month postoperative
measure: Change from baseline in SF36 Quality of Life Questionnaire at 36 month
timeFrame: Baseline and 36 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: UPMC - Department of Cardiothoracic Surgery
name: James D Luketich, MD
role: PRINCIPAL_INVESTIGATOR
References: