Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREtherapeutic conventional surgery
Undergo abdominal surgery
Undergo non-surgical management
OTHERquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Alive and Outside of the Hospital | From date of registration up to 91 days | Number of days alive and outside of the hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NG Tube Use | During initial hospitalization, from date of registration to a maximum of 53 weeks post registration | Use of a nasogastric tube |
| Days of NG Tube Use | During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration | Number of days a nasogastric tube was used during the patient's initial hospitalization |
| Number of Days in Hospital | During initial hospitalization, from date of registration to a maximum of 53 weeks post registration | Length of initial hospital stay in days. |
| Ability to Eat | Assessed at 5 weeks post registration | 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. |
| Overall Survival | From date of registration to maximum of 53 weeks | Time from date of registration to date of death due to any cause. |
| MDASI-GI Symptom Assessment | Assessed at 4 weeks post registration | 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. |
Countries
Canada, Colombia, Mexico, Peru, United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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 | 25 |
| 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 | 58 |
| 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 | 92 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 19 | 19 | 31 | 59 |
| Overall Study | Progression/relapse | 1 | 2 | 4 | 9 |
| Overall Study | Refusal unrelated to adverse event | 3 | 1 | 5 | 14 |
Baseline characteristics
| Characteristic | Total | Arm I (Randomized to Surgery) | Arm II (Randomized to Non-surgical Management) | Arm III (no Randomization, Surgery) | Arm IV (no Randomization, Non-surgical Management) |
|---|---|---|---|---|---|
| Admitting Attending Physician Specialty General Surgery | 18 Participants | 0 Participants | 1 Participants | 10 Participants | 7 Participants |
| Admitting Attending Physician Specialty Gynecologic Oncology | 42 Participants | 3 Participants | 4 Participants | 5 Participants | 30 Participants |
| Admitting Attending Physician Specialty Medical Specialty | 12 Participants | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Admitting Attending Physician Specialty Other | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Admitting Attending Physician Specialty Surgical Oncology | 124 Participants | 20 Participants | 16 Participants | 39 Participants | 49 Participants |
| Age, Continuous | 60.4 years | 63.4 years | 61.2 years | 61.1 years | 59.3 years |
| Age, Customized < 65 years | 131 Participants | 13 Participants | 17 Participants | 36 Participants | 65 Participants |
| Age, Customized >= 65 years | 68 Participants | 11 Participants | 8 Participants | 22 Participants | 27 Participants |
| Albumin, Child-Pugh <2.8 | 57 Participants | 7 Participants | 7 Participants | 18 Participants | 25 Participants |
| Albumin, Child-Pugh 2.8 - 3.5 | 75 Participants | 9 Participants | 11 Participants | 20 Participants | 35 Participants |
| Albumin, Child-Pugh >3.5 | 66 Participants | 8 Participants | 7 Participants | 20 Participants | 31 Participants |
| Albumin, Child-Pugh Missing | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Albumin, Continuous | 3.2 g/dL STANDARD_DEVIATION 0.7 | 3.1 g/dL STANDARD_DEVIATION 0.9 | 3.1 g/dL STANDARD_DEVIATION 0.7 | 3.2 g/dL STANDARD_DEVIATION 0.7 | 3.2 g/dL STANDARD_DEVIATION 0.7 |
| Ascites Evidence of ascites: large/massive amount | 39 Participants | 5 Participants | 6 Participants | 8 Participants | 20 Participants |
| Ascites Evidence of ascites: trace/small amount | 71 Participants | 11 Participants | 7 Participants | 24 Participants | 29 Participants |
| Ascites No evidence | 89 Participants | 8 Participants | 12 Participants | 26 Participants | 43 Participants |
| Body Mass Index (BMI), Categorical 18.5 - <25 (Normal) | 91 Participants | 10 Participants | 10 Participants | 26 Participants | 45 Participants |
| Body Mass Index (BMI), Categorical <18.5 (Underweight) | 18 Participants | 3 Participants | 2 Participants | 7 Participants | 6 Participants |
| Body Mass Index (BMI), Categorical 25 - <30 (Overweight) | 45 Participants | 6 Participants | 7 Participants | 12 Participants | 20 Participants |
| Body Mass Index (BMI), Categorical >=30 (Obese) | 45 Participants | 5 Participants | 6 Participants | 13 Participants | 21 Participants |
| Body Mass Index (BMI), Continuous | 24.6 kg/m^2 | 23.8 kg/m^2 | 25.7 kg/m^2 | 24.4 kg/m^2 | 24.7 kg/m^2 |
| Carcinomatosis Clear evidence: large/massive amount | 107 Participants | 14 Participants | 14 Participants | 26 Participants | 53 Participants |
| Carcinomatosis Clear evidence: trace/small amount | 9 Participants | 2 Participants | 4 Participants | 3 Participants | 0 Participants |
| Carcinomatosis No evidence | 67 Participants | 6 Participants | 5 Participants | 25 Participants | 31 Participants |
| Carcinomatosis Suspicion of carcinomatosis | 16 Participants | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Care Providers Family member | 171 Participants | 22 Participants | 21 Participants | 51 Participants | 77 Participants |
| Care Providers Hospice/Skilled nursing | 8 Participants | 1 Participants | 1 Participants | 0 Participants | 6 Participants |
| Care Providers No one | 19 Participants | 1 Participants | 2 Participants | 5 Participants | 11 Participants |
| Care Providers Other | 9 Participants | 0 Participants | 2 Participants | 4 Participants | 3 Participants |
| Number of Prior Malignant Bowel Obstructions (MBOs) At least one | 61 Participants | 5 Participants | 4 Participants | 21 Participants | 31 Participants |
| Number of Prior Malignant Bowel Obstructions (MBOs) Missing | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Number of Prior Malignant Bowel Obstructions (MBOs) None | 116 Participants | 17 Participants | 16 Participants | 32 Participants | 51 Participants |
| Number of Prior Malignant Bowel Obstructions (MBOs) Unknown | 19 Participants | 2 Participants | 4 Participants | 4 Participants | 9 Participants |
| Performance Status 0 | 37 Participants | 8 Participants | 5 Participants | 9 Participants | 15 Participants |
| Performance Status 1 | 94 Participants | 6 Participants | 9 Participants | 29 Participants | 50 Participants |
| Performance Status 2 | 68 Participants | 10 Participants | 11 Participants | 20 Participants | 27 Participants |
| Primary Cancer Site Colorectal | 57 Participants | 6 Participants | 7 Participants | 19 Participants | 25 Participants |
| Primary Cancer Site Gynecologic | 74 Participants | 10 Participants | 12 Participants | 14 Participants | 38 Participants |
| Primary Cancer Site Other | 68 Participants | 8 Participants | 6 Participants | 25 Participants | 29 Participants |
| Race/Ethnicity, Customized Ethnicity - Hispanic | 33 Participants | 9 Participants | 5 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Ethnicity - Non-Hispanic | 161 Participants | 14 Participants | 18 Participants | 51 Participants | 78 Participants |
| Race/Ethnicity, Customized Ethnicity - Unknown | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race - Black | 42 Participants | 6 Participants | 7 Participants | 13 Participants | 16 Participants |
| Race/Ethnicity, Customized Race - Other | 6 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race - Unknown | 9 Participants | 0 Participants | 0 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Race - White | 129 Participants | 9 Participants | 12 Participants | 39 Participants | 69 Participants |
| Sex: Female, Male Female | 129 Participants | 16 Participants | 15 Participants | 36 Participants | 62 Participants |
| Sex: Female, Male Male | 70 Participants | 8 Participants | 10 Participants | 22 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 24 | 20 / 25 | 37 / 58 | 68 / 92 |
| other Total, other adverse events | 5 / 24 | 1 / 25 | 12 / 58 | 14 / 92 |
| serious Total, serious adverse events | 2 / 24 | 3 / 25 | 5 / 58 | 16 / 92 |
Outcome results
Primary
Number of Days Alive and Outside of the Hospital
Number of days alive and outside of the hospital
Time frame: From date of registration up to 91 days
Population: Eligible and evaluable participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomization Surgery | Number of Days Alive and Outside of the Hospital | 42.6 days | Standard Deviation 32.2 |
| Randomization Non-surgical Management | Number of Days Alive and Outside of the Hospital | 43.9 days | Standard Deviation 29.5 |
| Patient Choice Surgery | Number of Days Alive and Outside of the Hospital | 54.8 days | Standard Deviation 27 |
| Patient Choice Non-surgical Management | Number of Days Alive and Outside of the Hospital | 52.7 days | Standard Deviation 30.7 |
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of good days between patients assigned to surgery and patients assigned to non-surgical management.p-value: 0.5Regression, Linear
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.
Time frame: Assessed at 5 weeks post registration
Population: Eligible and evaluable participants who were alive with data at the assessment time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomization Surgery | Ability to Eat | Eating | 12 Participants |
| Randomization Surgery | Ability to Eat | Not eating | 0 Participants |
| Randomization Non-surgical Management | Ability to Eat | Not eating | 0 Participants |
| Randomization Non-surgical Management | Ability to Eat | Eating | 12 Participants |
| Patient Choice Surgery | Ability to Eat | Eating | 29 Participants |
| Patient Choice Surgery | Ability to Eat | Not eating | 6 Participants |
| Patient Choice Non-surgical Management | Ability to Eat | Eating | 40 Participants |
| Patient Choice Non-surgical Management | Ability to Eat | Not eating | 7 Participants |
Comparison: A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.p-value: 0.52Regression, Logistic
Secondary
Days of NG Tube Use
Number of days a nasogastric tube was used during the patient's initial hospitalization
Time frame: During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomization Surgery | Days of NG Tube Use | 5.8 days | Standard Deviation 4.1 |
| Randomization Non-surgical Management | Days of NG Tube Use | 7.7 days | Standard Deviation 8.4 |
| Patient Choice Surgery | Days of NG Tube Use | 6.5 days | Standard Deviation 5.6 |
| Patient Choice Non-surgical Management | Days of NG Tube Use | 5.1 days | Standard Deviation 5.3 |
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.p-value: 0.47Regression, Linear
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.
Time frame: Assessed at 4 weeks post registration
Population: Eligible and evaluable participants who were alive with data at the time of the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomization Surgery | MDASI-GI Symptom Assessment | Bloating Severity | 1.5 score on a scale | Standard Deviation 2.3 |
| Randomization Surgery | MDASI-GI Symptom Assessment | Pain Severity | 2.9 score on a scale | Standard Deviation 3.1 |
| Randomization Surgery | MDASI-GI Symptom Assessment | Vomiting Severity | 0.64 score on a scale | Standard Deviation 2.1 |
| Randomization Surgery | MDASI-GI Symptom Assessment | Nausea Severity | 0.64 score on a scale | Standard Deviation 1.3 |
| Randomization Surgery | MDASI-GI Symptom Assessment | Constipation Severity | 0.55 score on a scale | Standard Deviation 1.3 |
| Randomization Non-surgical Management | MDASI-GI Symptom Assessment | Constipation Severity | 2.7 score on a scale | Standard Deviation 3.9 |
| Randomization Non-surgical Management | MDASI-GI Symptom Assessment | Pain Severity | 5.7 score on a scale | Standard Deviation 3.6 |
| Randomization Non-surgical Management | MDASI-GI Symptom Assessment | Vomiting Severity | 2.9 score on a scale | Standard Deviation 3.5 |
| Randomization Non-surgical Management | MDASI-GI Symptom Assessment | Nausea Severity | 4.6 score on a scale | Standard Deviation 3.8 |
| Randomization Non-surgical Management | MDASI-GI Symptom Assessment | Bloating Severity | 3.9 score on a scale | Standard Deviation 3.2 |
| Patient Choice Surgery | MDASI-GI Symptom Assessment | Bloating Severity | 1.6 score on a scale | Standard Deviation 2.4 |
| Patient Choice Surgery | MDASI-GI Symptom Assessment | Nausea Severity | 1.9 score on a scale | Standard Deviation 3.1 |
| Patient Choice Surgery | MDASI-GI Symptom Assessment | Vomiting Severity | 0.58 score on a scale | Standard Deviation 1.5 |
| Patient Choice Surgery | MDASI-GI Symptom Assessment | Pain Severity | 4.1 score on a scale | Standard Deviation 3.3 |
| Patient Choice Surgery | MDASI-GI Symptom Assessment | Constipation Severity | 0.77 score on a scale | Standard Deviation 2.2 |
| Patient Choice Non-surgical Management | MDASI-GI Symptom Assessment | Pain Severity | 3.8 score on a scale | Standard Deviation 3.6 |
| Patient Choice Non-surgical Management | MDASI-GI Symptom Assessment | Vomiting Severity | 1.9 score on a scale | Standard Deviation 3 |
| Patient Choice Non-surgical Management | MDASI-GI Symptom Assessment | Nausea Severity | 2.3 score on a scale | Standard Deviation 3 |
| Patient Choice Non-surgical Management | MDASI-GI Symptom Assessment | Bloating Severity | 2.3 score on a scale | Standard Deviation 2.9 |
| Patient Choice Non-surgical Management | MDASI-GI Symptom Assessment | Constipation Severity | 2.2 score on a scale | Standard Deviation 3.4 |
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.p-value: 0.001Regression, Linear
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.p-value: 0.008Regression, Linear
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.p-value: 0.04Regression, Linear
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.p-value: 0.01Regression, Linear
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.p-value: 0.007Regression, Linear
Secondary
NG Tube Use
Use of a nasogastric tube
Time frame: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Population: Eligible and evaluable participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomization Surgery | NG Tube Use | Yes | 19 Participants |
| Randomization Surgery | NG Tube Use | Missing | 0 Participants |
| Randomization Surgery | NG Tube Use | No | 5 Participants |
| Randomization Non-surgical Management | NG Tube Use | Yes | 20 Participants |
| Randomization Non-surgical Management | NG Tube Use | Missing | 0 Participants |
| Randomization Non-surgical Management | NG Tube Use | No | 5 Participants |
| Patient Choice Surgery | NG Tube Use | No | 13 Participants |
| Patient Choice Surgery | NG Tube Use | Yes | 42 Participants |
| Patient Choice Surgery | NG Tube Use | Missing | 3 Participants |
| Patient Choice Non-surgical Management | NG Tube Use | Yes | 69 Participants |
| Patient Choice Non-surgical Management | NG Tube Use | Missing | 2 Participants |
| Patient Choice Non-surgical Management | NG Tube Use | No | 21 Participants |
Comparison: A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.p-value: 0.6Regression, Logistic
Secondary
Number of Days in Hospital
Length of initial hospital stay in days.
Time frame: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Population: Eligible and evaluable participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomization Surgery | Number of Days in Hospital | 12.3 days | Standard Deviation 9.3 |
| Randomization Non-surgical Management | Number of Days in Hospital | 12.8 days | Standard Deviation 12.2 |
| Patient Choice Surgery | Number of Days in Hospital | 11.6 days | Standard Deviation 7.8 |
| Patient Choice Non-surgical Management | Number of Days in Hospital | 6.2 days | Standard Deviation 6.6 |
Comparison: A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.p-value: 0.64Regression, Linear
Secondary
Overall Survival
Time from date of registration to date of death due to any cause.
Time frame: From date of registration to maximum of 53 weeks
Population: Eligible and evaluable participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomization Surgery | Overall Survival | 86 days |
| Randomization Non-surgical Management | Overall Survival | 80 days |
| Patient Choice Surgery | Overall Survival | 156 days |
| Patient Choice Non-surgical Management | Overall Survival | 96 days |
Comparison: A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.p-value: 0.1295% CI: [0.45, 1.09]Regression, Cox