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Clinical Trial 19100
Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
Phase of Study: Phase IV
- Jose Pimiento
Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
The purpose of this study is to enroll two groups of study participants to compare the quality of life of patients with Malignant Bowel Obstruction (MBO) who are treated with surgery to that of similar patients who are treated with the best medical management (non-surgical treatment).
1.1 Primary Objective To compare quality of life, as assessed by the number of days alive and outside of the hospital within the first 91 days (13 weeks) after registration, among patients with malignant bowel obstruction (MBO) who receive surgical intervention and similar patients treated non-surgically. 1.2 Other Objectives a. To explore whether there are differences in other health related quality of life (HRQOL) factors of particular interest in this population, including ability to eat, days with nasogastric tube, development of nausea, days of intravenous hydration, days eating solid foods and days drinking that are different for patients with MBO who receive surgical intervention as compared to non-surgical intervention. b. To explore whether overall survival is different for patients with MBO who receive surgical intervention as compared to non-surgical intervention. c. To estimate the effects of surgical versus non-surgical management on quality of life after adjustment for non-adherence to initially assigned/chosen treatment. d. To explore whether there are clinical factors (e.g., ascites, albumin, carcinomatosis) that predict better quality of life outcomes for patients with malignant bowel obstruction who receive surgical intervention as compared to non-surgical intervention.