Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT00140868
Eligibility Criteria:
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 other impairment which causes an inability to complete the quality of life questionnaires
* unable or unwilling to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00140868
Study Brief:
Protocol Section:
NCT00140868