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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037429 | U.S. NIH Grant/Contract | View source | |
| 1R01HS021491-01A1 | U.S. AHRQ Grant/Contract | View source | |
| S1316 | Other Identifier | SWOG | |
| NCI-2014-01497 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (randomized to surgery) | Experimental | Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. |
|
| Arm II (randomized to non-surgical management) | Experimental | Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. |
|
| Arm III (no randomization, surgery) | Experimental | Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I. |
|
| Arm IV (no randomization, non-surgical management) | Experimental | Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Undergo abdominal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Alive and Outside of the Hospital | Number of days alive and outside of the hospital | From date of registration up to 91 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days in Hospital | Length of initial hospital stay in days. | During initial hospitalization, from date of registration to a maximum of 53 weeks post registration |
| NG Tube Use | Use of a nasogastric tube |
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Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Krouse, M.D., F.A.C.S. | University of Arizona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center at Saint Joseph's | Phoenix | Arizona | 85004 | United States | ||
| Banner University Medical Center - Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37541263 | Derived | 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. |
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221 patients were initially enrolled. 19 were ineligible: 12 with no small bowel obstruction, 3 with no confirmed bowel obstruction, 3 who were treated prior to registration and 1 with no intra-abdominal cancer. Another 3 patients were ineligible for analysis, due to withdrawal of consent prior to the end of their first hospitalization. In all, 199 patients were treated and evaluable for analysis: 49 randomized (24 surgery; 25 non-surgery) and 150 non-randomized (58 surgery; 92 non-surgery).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm II (Randomized to Non-surgical Management) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 18, 2019 |
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| gastrointestinal complications management/prevention | Procedure | Undergo non-surgical management |
|
|
| quality-of-life assessment | Other | Ancillary studies |
|
|
| During initial hospitalization, from date of registration to a maximum of 53 weeks post registration |
| Days of NG Tube Use | Number of days a nasogastric tube was used during the patient's initial hospitalization | During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration |
| MDASI-GI Symptom Assessment | The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes. | Assessed at 4 weeks post registration |
| Ability to Eat | Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research. | Assessed at 5 weeks post registration |
| Overall Survival | Time from date of registration to date of death due to any cause. | From date of registration to maximum of 53 weeks |
| Tucson |
| Arizona |
| 85719 |
| United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| South Shore University Hospital | Bay Shore | New York | 11706 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Methodist Le Bonheur Germantown Hospital | Germantown | Tennessee | 38138 | United States |
| The West Clinic - Wolf River | Germantown | Tennessee | 38138 | United States |
| Methodist Hospital | Memphis | Tennessee | 38104 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University Hospital | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Valley Health / Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Instituto Nacional De Cancerologia | Bogotá | 99999 | Colombia |
| Instituto Nacional De Cancerologia de Mexico | Mexico City | Tlalpan | 14080 | Mexico |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | Lima 34 | Peru |
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 |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible and evaluable participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Race and ethnicity are categorized separately. | Race was not applicable for participants from Mexico and Peru. | Count of Participants | Participants |
| |||||||||
| Primary Cancer Site | Count of Participants | Participants |
| |||||||||||
| Body Mass Index (BMI), Continuous | Median | Full Range | kg/m^2 |
| ||||||||||
| Body Mass Index (BMI), Categorical | Count of Participants | Participants |
| |||||||||||
| Albumin, Continuous | Number of participants analyzed differs from overall number of baseline participants due to missing data. | Mean | Standard Deviation | g/dL |
| |||||||||
| Albumin, Child-Pugh | Count of Participants | Participants |
| |||||||||||
| Ascites | Count of Participants | Participants |
| |||||||||||
| Carcinomatosis | Count of Participants | Participants |
| |||||||||||
| Performance Status | Participants were graded according to the Zubrod Performance Status Scale: 0 - Fully active, able to carry on all pre-disease performance without restriction.1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. | Count of Participants | Participants |
| ||||||||||
| Number of Prior Malignant Bowel Obstructions (MBOs) | Count of Participants | Participants |
| |||||||||||
| Care Providers | Participants may have had more than one care provider. | Count of Participants | Participants |
| ||||||||||
| Admitting Attending Physician Specialty | "Medical Specialty" includes Family practice, Internal medicine, and Medical oncology. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days Alive and Outside of the Hospital | Number of days alive and outside of the hospital | Eligible and evaluable participants | Posted | Mean | Standard Deviation | days | From date of registration up to 91 days |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days in Hospital | Length of initial hospital stay in days. | Eligible and evaluable participants | Posted | Mean | Standard Deviation | days | During initial hospitalization, from date of registration to a maximum of 53 weeks post registration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | NG Tube Use | Use of a nasogastric tube | Eligible and evaluable participants | Posted | Count of Participants | Participants | During initial hospitalization, from date of registration to a maximum of 53 weeks post registration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days of NG Tube Use | Number of days a nasogastric tube was used during the patient's initial hospitalization | Eligible and evaluable participants. Number of participants analyzed in the Patient Choice Surgery arm and Patient Choice Non-surgical Management arm differs from the overall number of eligible and evaluable participants due to missing data. | Posted | Mean | Standard Deviation | days | During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MDASI-GI Symptom Assessment | The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes. | Eligible and evaluable participants who were alive with data at the time of the assessment | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 weeks post registration |
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| Secondary | Ability to Eat | Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research. | Eligible and evaluable participants who were alive with data at the assessment time | Posted | Count of Participants | Participants | Assessed at 5 weeks post registration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from date of registration to date of death due to any cause. | Eligible and evaluable participants | Posted | Median | 95% Confidence Interval | days | From date of registration to maximum of 53 weeks |
|
From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomization Surgery | Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. | 19 | 24 | 2 | 24 | 5 | 24 |
| EG001 | Randomization Non-surgical Management | Patients on the randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. | 20 | 25 | 3 | 25 | 1 | 25 |
| EG002 | Patient Choice Surgery | Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1. | 37 | 58 | 5 | 58 | 12 | 58 |
| EG003 | Patient Choice Non-surgical Management | Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2. | 68 | 92 | 16 | 92 | 14 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Death NOS | General disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Neoplasms benign, malignant and unspecified - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Renal and urinary disorders-Other | Renal and urinary disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Gastrointestinal fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Palliative and End of Life Care Committee Statistician | SWOG Statistics and Data Management Center | 2066674623 | karnold@fredhutch.org |
| Jul 21, 2022 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
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| >= 65 years |
|
|
|
|
| Race - White |
|
|
| Race - Other |
|
|
| Race - Unknown |
|
|
| Ethnicity - Hispanic |
|
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| Ethnicity - Non-Hispanic |
|
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| Ethnicity - Unknown |
|
|
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| Gynecologic |
|
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| Other |
|
|
|
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| 18.5 - <25 (Normal) |
|
|
| 25 - <30 (Overweight) |
|
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| >=30 (Obese) |
|
|
|
|
| 2.8 - 3.5 |
|
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| >3.5 |
|
|
| Missing |
|
|
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| Evidence of ascites: trace/small amount |
|
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| Evidence of ascites: large/massive amount |
|
|
|
| Suspicion of carcinomatosis |
|
|
| Clear evidence: trace/small amount |
|
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| Clear evidence: large/massive amount |
|
|
|
| 1 |
|
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| 2 |
|
|
|
| At least one |
|
|
| Unknown |
|
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| Missing |
|
|
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| Hospice/Skilled nursing |
|
|
| Other |
|
|
| No one |
|
|
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| General Surgery |
|
|
| Gynecologic Oncology |
|
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| Surgical Oncology |
|
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| Other |
|
|
Comparing surgery to non-surgical management. |
| Superiority |
|
|
|
|
|
|
| Patient Choice Non-surgical Management |
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2. |
|
|
|
| OG003 | Patient Choice Non-surgical Management | Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2. |
|
|
|
| OG003 |
| Patient Choice Non-surgical Management |
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2. |
|
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|
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|
|