Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery (NCT00140868) | Clinical Trial Compass
CompletedPhase 3
Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery
United States180 participantsStarted 2002-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 othe…
What they're measuring
1
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.