Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery

Completed · Phase 3

Conditions studied: Large Bowel Obstruction

In brief

The purpose of this study is to assess quality of life and bowel symptoms after treatment.The 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.

Key facts

Study ID

NCT00140868

Run by

Memorial Sloan Kettering Cancer Center

People needed

180

Starts

2002-12-01

Expected to finish

2006-10-01

Last updated by the study team

2007-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• men and women over 18 years of age
• presentation of large bowel obstruction based on clinical symptoms AND an imaging study.
• clinical symptoms: one of : progressive constipation, multiple small liquid bowel movements daily, abdominal distention, abdominal pain or nausea and vomiting.
• imaging study: one of: CT scan, barium or gastrograffin enema, flexible sigmoidoscopy or colonoscopy, showing any degree of colonic narrowing by tumor.
• large bowel obstruction due to stage IV colorectal cancer unresectable for cure OR unresectable local-regional colorectal cancer OR unresectable extra-colonic cancer (such as gastric, ovarian, prostate, pancreatic cancers).
• ability to give informed consent, indicating the investigational nature of this study in keeping with the policies of Memorial Sloan-Kettering Cancer Center.

You may not qualify if…

• presence of acute bowel perforation
• presence of a second synchronous large or small bowel obstruction site
• contra-indication to stent placement:
• obstruction greater than 12 cm in length (ie precluding treatment with one stent)
• obstruction located within 2 cm of dentate line
• contra-indication to laparoscopy:
• presence of MI, unstable angina, or CVA in the previous four weeks
• tense ascites
• uncorrectable coagulopathy
• prior abdominal surgery with known prohibitive adhesions
• prior PALLIATIVE treatment of malignant large bowel obstruction with surgery or stent
• inability to speak or read English, or other impairment which causes an inability to complete the quality of life questionnaires
• unable or unwilling to give informed consent

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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