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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00260559
Other study ID # STUDY20040382
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1999
Est. completion date December 2050

Study information

Verified date February 2024
Source University of Pittsburgh
Contact Julie A Ward, BSN
Phone 412-647-8583
Email wardj@upmc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3500
Est. completion date December 2050
Est. primary completion date December 2050
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Questionnaires
Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.

Locations

Country Name City State
United States University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery Pittsburgh Pennsylvania
United States UPMC - Hillman Cancer Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in SF36 Quality of Life Questionnaire at 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. Baseline and 4 month postoperative
Primary Change from baseline in SF36 Quality of Life Questionnaire at 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. Baseline and 6 month postoperative
Primary Change from baseline in SF36 Quality of Life Questionnaire at 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. Baseline and 12 month postoperative
Primary Change from baseline in SF36 Quality of Life Questionnaire at 18 month 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. Baseline and 18 month postoperative
Primary Change from baseline in SF36 Quality of Life Questionnaire at 24 month 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. Baseline and 24 month postoperative
Primary Change from baseline in SF36 Quality of Life Questionnaire at 30 month 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. Baseline and 30 month postoperative
Primary Change from baseline in SF36 Quality of Life Questionnaire at 36 month 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. Baseline and 36 month postoperative
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