S1316 - Malignant Bowel Obstruction - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare the quality of life for participants with malignant bowel obstruction who are treated with surgery to that of similar participants who are treated with the best medical management (non-surgical treatment).
What is the Condition Being Studied?
Malignant bowel obstruction

Who Can Participate in the Study?

Adults with malignant bowel obstruction.

Age Group

What is Involved?

If you agree to be in the study you will:
Be randomized (like a flip of a coin) to one of two standard malignant bowel treatments.
-- Group 1 participants will receive the usual abdominal surgery for malignant bowel obstruction.
-- Group 2 participants will receive the usual non-surgical treatment for malignant bowel obstruction.

Weekly telephone call (or hospital visits if you are in the hospital) for 13 weeks from the start of the study and then monthly telephone calls for up to 1 year. Each telephone call or hospital visit will last for about 15 minutes.

Monthly telephone calls from the Arizona Diet, Behavior, and Quality of Life Assessment Lab to find out what you are eating. Each telephone call will last for about 15-20 minutes.

Study Details

Full Title
S1316: Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00058895
NCT: NCT02270450
Phase III
Contact the Duke Recruitment Innovation Center