Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for MIE (Minimally Invasive Esophagectomy)
Patients scheduled for open esophagectomy
Signed informed consent
Disqualifiers
Patients who are unable to comprehend or complete the QOL instruments.
Patients less than 18 years of age.
Trial population
Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Procedure/SurgeryQuality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 4 month postoperative2
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.
Time frame
Baseline and 6 month postoperative3
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.
Time frame
Baseline and 12 month postoperative4
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.
Time frame
Baseline and 18 month postoperativeSponsors and contacts
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Source ClinicalTrials.gov