S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bo… (NCT02270450) | Clinical Trial Compass
CompletedNot Applicable
S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
United States221 participantsStarted 2015-03-09
Plain-language summary
This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.
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.
* Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:
* Clinical evidence of a bowel obstruction (via history, physical, and radiographic examination)
* Bowel obstruction below (distal to) ligament of Treitz
* Intra-abdominal primary cancer with incurable disease
* Patients must have malignant bowel obstruction due to an intra-abdominal primary cancer (i.e. stomach, small bowel \[including duodenum\], pancreas, colon, rectum, appendiceal, ovarian, uterine, cervical, kidney, bladder, prostate, gastrointestinal stromal tumor \[GIST\] \[all sites\], and sarcoma)
* Patient must be able to tolerate a major surgical procedure based on clinical evaluation, status of their cancer, and any other underlying medical problems
* A member of the patient's surgical team must indicate equipoise for the benefit of the surgical treatment for MBO; the surgeon must respond "Yes" to each of the following questions and sign the S1316 Surgical Equipoise Documentation form for the patient to be eligible:
* Is surgery for treatment of malignant bowel obstruction (MBO) being considered for this patient?
* Do you have equipoise (If the treating team finds that an operation is required \[e.g., for acute abdomen\], or they would not offer the patient an operation \[e.g., patient is too weak to tolerate surgery\], then there is no equipoise)?
* Patients must not have signs of bowel perforation or "acute" abdomen as evidenced by free air on radiologic imagi…
What they're measuring
1
Number of Days Alive and Outside of the Hospital
Timeframe: From date of registration up to 91 days