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This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT - Negative Pressure Wound Therapy | Experimental | Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed. |
|
| Standard of Care Wound Therapy | No Intervention | Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection - Superficial Incisional | Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions. | 30 days post operation |
| Surgical Site Infection - Deep Incisional | Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions. | 30 days post operation |
| Surgical Site Infection - Organ/Space Incisional | Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions. | 30 days post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Return to Intended Oncologic Therapy (RIOT) | Investigators will measure number of participants who returned to their intended oncologic therapy | Up to 12 months after surgery |
| Time to Initiation of Planned Oncologic Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose M Pimiento, MD | Moffitt Cancer Center | Principal Investigator |
| Daniel Anaya, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trial Search | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPWT - Negative Pressure Wound Therapy | Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed. Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery. |
| FG001 | Standard of Care Wound Therapy | Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NPWT - Negative Pressure Wound Therapy | Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed. Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Surgical Site Infection - Superficial Incisional | Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions. | All participants were evaluated | Posted | Count of Participants | Participants | 30 days post operation |
|
6 months
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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 | NPWT - Negative Pressure Wound Therapy | Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed. Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose M. Pimiento, MD | Moffitt Cancer Center | 813-745-3237 | Jose.Pimiento@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Jan 5, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2022 | Jan 5, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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Participants, investigators and statisticians will be blinded to treatment randomization. Surgical oncologists will be blinded of treatment randomization until the dressing is applied to the wound.
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Investigators will measure time to initiation planned therapy from the surgery date to initiation date of planned oncologic therapy
| Up to 12 months after surgery |
| BG001 | Standard of Care Wound Therapy | Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Standard of Care Wound Therapy | Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed. |
|
|
| Primary | Surgical Site Infection - Deep Incisional | Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions. | All participants were evaluated | Posted | Count of Participants | Participants | 30 days post operation |
|
|
|
| Primary | Surgical Site Infection - Organ/Space Incisional | Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions. | All participants were evaluated | Posted | Count of Participants | Participants | 30 days post operation |
|
|
|
| Secondary | Return to Intended Oncologic Therapy (RIOT) | Investigators will measure number of participants who returned to their intended oncologic therapy | All participants were evaluated | Posted | Number | percentage of participants | Up to 12 months after surgery |
|
|
|
| Secondary | Time to Initiation of Planned Oncologic Therapy | Investigators will measure time to initiation planned therapy from the surgery date to initiation date of planned oncologic therapy | All participants were evaluated | Posted | Median | 95% Confidence Interval | Months | Up to 12 months after surgery |
|
|
|
| 3 |
| 194 |
| 36 |
| 194 |
| 62 |
| 194 |
| EG001 | Standard of Care Wound Therapy | Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed. | 4 | 96 | 18 | 96 | 29 | 96 |
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Chylous ascites | Gastrointestinal disorders | Systematic Assessment |
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| Esophageal fistula | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | Systematic Assessment |
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| Perforation bile duct | Hepatobiliary disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Abdominal infection | Infections and infestations | Systematic Assessment |
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| Bacteremia | Infections and infestations | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
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| Pancreas infection | Infections and infestations | Systematic Assessment |
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| Pleural infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Esophageal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pancreatic anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Postoperative hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Vasovagal reaction | Nervous system disorders | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Delirium | Psychiatric disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Hematoma | Vascular disorders | Systematic Assessment |
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| Chylous ascites | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Esophageal fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | Systematic Assessment |
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| Gastroparesis | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
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| Peritoneal infection | Infections and infestations | Systematic Assessment |
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| Pleural infection | Infections and infestations | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
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| Bronchial infection | Infections and infestations | Systematic Assessment |
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| Pancreas infection | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flu like symptoms | General disorders | Systematic Assessment |
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| Gait disturbance | General disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
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| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | Systematic Assessment |
|
| Perforation bile duct | Hepatobiliary disorders | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | Systematic Assessment |
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| Delirium | Psychiatric disorders | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Endocrine disorders - Other, specify | Endocrine disorders | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |