S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
NCT ID: NCT02270450
Last Updated: 2023-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
221 participants
INTERVENTIONAL
2015-03-09
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (randomized to surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
therapeutic conventional surgery
Undergo abdominal surgery
quality-of-life assessment
Ancillary studies
Arm II (randomized to non-surgical management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
gastrointestinal complications management/prevention
Undergo non-surgical management
quality-of-life assessment
Ancillary studies
Arm III (no randomization, surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
therapeutic conventional surgery
Undergo abdominal surgery
quality-of-life assessment
Ancillary studies
Arm IV (no randomization, non-surgical management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
gastrointestinal complications management/prevention
Undergo non-surgical management
quality-of-life assessment
Ancillary studies
Interventions
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therapeutic conventional surgery
Undergo abdominal surgery
gastrointestinal complications management/prevention
Undergo non-surgical management
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 imaging or peritonitis on physical exam within 2 days prior to registration
* Patients must be registered to the study within 3 days after surgical consult for MBO and prior to any treatment (surgical or non-surgical) for MBO
* Patients must have Zubrod performance status of 0-2 within 7 days prior to registration
* Serum albumin must be planned to be collected after admission, but prior to treatment
* Patients must be able to complete the study questionnaires in English
* Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Patients must consent and provide both their contact information and that of their representative for a monthly 24-hour dietary recall phone call to be conducted by the Arizona Diet, Behavior and Quality of Life Assessment Lab
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Agency for Healthcare Research and Quality (AHRQ)
FED
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Robert S Krouse, M.D., F.A.C.S.
Role: STUDY_CHAIR
University of Arizona
Locations
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Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
South Shore University Hospital
Bay Shore, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Le Bonheur Germantown Hospital
Germantown, Tennessee, United States
The West Clinic - Wolf River
Germantown, Tennessee, United States
Methodist Hospital
Memphis, Tennessee, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Valley Health / Winchester Medical Center
Winchester, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Instituto Nacional De Cancerologia
Bogotá, , Colombia
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Countries
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References
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Krouse RS, Anderson GL, Arnold KB, Thomson CA, Nfonsam VN, Al-Kasspooles MF, Walker JL, Sun V, Alvarez Secord A, Han ES, Leon-Takahashi AM, Isla-Ortiz D, Rodgers P, Hendren S, Sanchez Salcedo M, Laryea JA, Graybill WS, Flaherty DC, Mogal H, Miner TJ, Pimiento JM, Kitano M, Badgwell B, Whalen G, Lamont JP, Guevara OA, Senthil MS, Dewdney SB, Silberfein E, Wright JD, Friday B, Fahy B, Anantha Sathyanarayana S, O'Rourke M, Bakitas M, Sloan J, Grant M, Deutsch GB, Deneve JL. Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial. Lancet Gastroenterol Hepatol. 2023 Oct;8(10):908-918. doi: 10.1016/S2468-1253(23)00191-7. Epub 2023 Aug 1.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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S1316
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2014-01497
Identifier Type: OTHER
Identifier Source: secondary_id
S1316
Identifier Type: -
Identifier Source: org_study_id
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