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

Sponsor

University of Pittsburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT00260559

Collaborator

(none)

3,500

Enrollment

Locations

619

Duration (Months)

1750

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophagectomy Esophageal Cancer	Procedure: Questionnaires

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 Design

Study Type:

Observational

Anticipated Enrollment :

3500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 1999

Anticipated Primary Completion Date :

Dec 1, 2050

Anticipated Study Completion Date :

Dec 1, 2050

Outcome Measures

Primary Outcome Measures

Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative [Baseline and 4 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative [Baseline and 6 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative [Baseline and 12 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 18 month [Baseline and 18 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 24 month [Baseline and 24 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 30 month [Baseline and 30 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 36 month [Baseline and 36 month postoperative]
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery	Pittsburgh	Pennsylvania	United States	15213
2	UPMC - Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232