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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00260559
• Other study ID #: STUDY20040382
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophagectomy

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