Quality of Life After Esophagectomy for Cancer
Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer
1 other identifier
observational
88
1 country
1
Brief Summary
The purpose of the current study is to assess the role of pyloric drainage procedure on altering the reflux effect on the quality of life in patients who underwent esophagectomy. Researchers hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 31, 2012
July 1, 2012
1.5 years
November 25, 2008
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reflux Symptoms: Open Esophagectomy versus Minimally Invasive
Comparison of reflux symptoms in patients who underwent open esophagectomies with pyloric drainage and those who received minimally invasive esophagectomies without pyloric drainage. The survey consisted of ten questions regarding symptoms associated with reflux using Gastrointestinal Symptoms Rating Scale (GSRS). Responses to degree of reflux distress rated on a six-point scale for questions with "0" indicating no heartburn symptoms and "5" indicating most symptoms experienced.
Survey response collected at single point in time.
Study Arms (2)
Pyloric Drainage Procedure
Esophagectomy with pyloric drainage procedure
No Pyloric Drainage Procedure
Esophagectomy without pyloric drainage procedure
Interventions
Ten questions regarding symptoms of reflux
Eligibility Criteria
Adults who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy for primary esophageal cancer at MDACC during or after 2004.
You may qualify if:
- patients who are 18 years-old or older
- Patients who received esophagectomy indicated for primary esophageal cancer, either adenocarcinoma or squamous cell carcinoma
- Patients who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy at MDACC during or after 2004
- Patients who are English-speaking and of any ethnicity
- Patients with prior cancers, any clinical stage of esophageal carcinoma, any performance status (as rated by American Society of Anesthesiologist Risk Scale), received or did not receive preoperative treatment, had level of anastomosis in either neck or chest
You may not qualify if:
- \) Patients who received esophagectomies indicated for emergency, salvage or redo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reza J. Mehran, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
November 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 31, 2012
Record last verified: 2012-07