Actively Recruiting
Outcomes After Esophagectomy Focusing on Minimally Invasive Surgery and Quality of Life
Led by University of Pittsburgh · Updated on 2026-04-14
3500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the short and long-term outcomes of minimally invasive esophagectomy (MIE) compared to open esophagectomy in patients undergoing surgery for esophageal cancer. They aim to measure both standard clinical results such as complications, mortality, and tumor recurrence, as well as patient-reported outcomes focused on quality of life (QOL). The study also seeks to determine how well the MOS SF36 questionnaire reflects changes in patients' health status before and after surgery, and to compare it with disease-specific measures of swallowing difficulties and reflux symptoms. Participants in this observational study complete quality of life and heartburn assessment questionnaires before surgery and at scheduled times after surgery. The study monitors changes in QOL at multiple time points, including 4, 6, 12, 18, 24, 30, and 36 months post-surgery. It also assesses the impact of additional treatments given before or after surgery on patient quality of life. Throughout the study, researchers collect and analyze questionnaire data to evaluate changes in patient well-being over time. The primary outcome is the change from baseline in the SF36 Quality of Life Questionnaire at each postoperative interval. Participants provide consent and complete the assessments as part of their involvement. The study continues to monitor these outcomes long term, with participation extending up to 36 months after surgery.
CONDITIONS
Brief Title
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for minimally invasive esophagectomy (MIE)
- Patients scheduled for open esophagectomy
- Signed informed consent
You will not qualify if you...
- Patients unable to understand or complete quality of life questionnaires
- Patients younger than 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 week before surgery
Participants complete quality of life and heartburn assessment questionnaires before surgery to establish baseline status.
1 visit (in-person or remote)
Duration - Up to 2 weeks or until discharge
Participants undergo minimally invasive or open esophagectomy and receive immediate post-operative care.
Hospital stay and care visits
Duration - Up to 36 months post-surgery
Participants complete follow-up quality of life questionnaires and are monitored for outcomes such as morbidity, mortality, and tumor recurrence.
1 baseline visit and multiple follow-up visits at 4, 6, 12, 18, 24, 30, and 36 months
Trial Site Locations
Total: 2 locations
1
University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
J
Julie A Ward, BSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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