Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery
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|ClinicalTrials.gov Identifier: NCT00140868|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : December 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Large Bowel Obstruction||Device: Luminal stents Procedure: Minimally Invasive Surgical Bowel Diversion||Phase 3|
Large bowel obstruction is a common presentation among cancer patients, including those with non-colorectal malignancies. This study will evaluate patients with malignant large bowel obstruction who undergo palliative treatment with minimally invasive surgical diversion or endoscopic colorectal stent placement, in terms quality of life, symptom relief from bowel obstruction, and treatment-related complications. Assessments in changes in quality of life and symptom relief over time for each group will be done.
Traditionally malignant bowel obstruction is treated with surgery. In the last decade, creation of an ostomy can be completed with minimally invasive surgery, which reduces morbidity, mortality, and recovery time.wishes.
In the last several years, endoscopically inserted colorectal stents have emerged as an option for palliative treatment. This involves a simple procedure, often completed on an outpatient basis. This allows the intestinal lumen to remain open without the need for surgery.
- Primary Objective: is to compare the effect on quality of life of minimally invasive surgical bowel diversion and endoscopic stent placement in the treatment of malignant large bowel obstruction.
- Secondary Objectives: are to evaluate the symptom response (including abdominal pain, distention, bowel frequency and consistency, and nausea and emesis) and complication rate of treatment of malignant large bowel obstruction with endoscopic stent placement or minimally invasive surgical bowel diversion.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outcome of Palliative Management of Malignant Large Bowel Obstruction With Colorectal Stents or Surgery|
|Study Start Date :||December 2002|
|Actual Study Completion Date :||October 2006|
- Primary objective: compare the effect on quality of life of minimally invasive surgical bowel diversion and endoscopic stent placement in the treatment of malignant large bowel obstruction.
- Secondary objectives:the symptom response and complication rate of treatment of malignant large bowel obstruction with endoscopic stent placement or minimally invasive surgical bowel diversion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140868
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Hans Gerdes, M.D.||Memorial Sloan Kettering Cancer Center|