Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140868
Status:
COMPLETED
Last Update Posted:
2007-12-10
First Post:
2005-08-30
Brief Title:
Outcome of Palliative Management of Malignant Large Bowel Obstruction wColorectal Stents or Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Outcome of Palliative Management of Malignant Large Bowel Obstruction With Colorectal Stents or Surgery
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess quality of life and bowel symptoms after treatmentThe main objective is to compare the effect on quality of life of minimally invasive bowel surgery and endoscopic stent placement in the treatment of malignant large bowel obstruction
Detailed Description:
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 timewishes
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
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 timewishes
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None