Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MHLW H26-Special-047 | Other Grant/Funding Number | Ministry of Health, Labour and Welfare, Japan | |
| NCGG 25-11 | Other Grant/Funding Number | National Center for Geriatrics and Gerontology , Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.
Data were acquired from patients selected from a national inpatient database covering 1,057 hospitals in Japan. Participants had received artificial nutrition between April 2012 and March 2013, were 20 years or older, and did not have cancer. Participants were grouped into two groups: those receiving parenteral nutrition and those receiving enteral nutrition. The investigators performed one-to-one propensity-score matching between the groups. The primary outcome measurements were mortality rates at 30 and 90 days after the start of the procedure. The secondary outcomes were post-procedural complications, pneumonia, and sepsis. The investigators analyzed survival length of stay after the procedure using a Cox proportional hazards model.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition | investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013. |
| |
| Enteral nutrition | investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral nutrition | Device | Participants are retrospectively selected with propensity score matching |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Calculated From Outcome Section From DPC Database at 90 Days | 90 days after the start of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedural Pneumonia | the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure. | |
| Post-procedural Sepsis | the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
For this study, the investigators used the Japanese Diagnosis Procedure Combination database, the details of which have been described elsewhere. The database includes administrative claims and discharge abstract data. In 2012, these data were collected for about seven million inpatients from 1,057 participating hospitals across Japan, which amounted to about half of the acute-care hospitalizations in the country.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sumito Ogawa, MD. PhD. | Tokyo University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26447149 | Derived | Tamiya H, Yasunaga H, Matusi H, Fushimi K, Akishita M, Ogawa S. Comparison of short-term mortality and morbidity between parenteral and enteral nutrition for adults without cancer: a propensity-matched analysis using a national inpatient database. Am J Clin Nutr. 2015 Nov;102(5):1222-8. doi: 10.3945/ajcn.115.111831. Epub 2015 Oct 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Parenteral Nutrition | investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching |
| FG001 | Enteral Nutrition | investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Parenteral Nutrition | investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Mortality Calculated From Outcome Section From DPC Database at 90 Days | Posted | Number | Participants | 90 days after the start of the procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parenteral Nutrition | investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sumito Ogawa | The University of Tokyo Hospital | +81-3-5800-8830 | suogawa-tky@umin.ac.jp |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enteral nutrition | Device | Participants are retrospectively selected with propensity score matching |
|
| Re-admission 30 Days | re-admission within 30 days of discharge. |
| Mortality Calculated From Outcome Section From DPC Database at 14 Days | 14 days after the start of the procedure |
| Mortality Calculated From Outcome Section From DPC Database at 30 Days | 30 days after the start of the procedure |
| Enteral Nutrition |
investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Post-procedural Pneumonia | Posted | Number | Participants | the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure. |
|
|
|
| Secondary | Post-procedural Sepsis | Posted | Number | Participants | the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure. |
|
|
|
| Secondary | Re-admission 30 Days | Posted | Number | Participants | re-admission within 30 days of discharge. |
|
|
|
| Secondary | Mortality Calculated From Outcome Section From DPC Database at 14 Days | Posted | Number | Participants | 14 days after the start of the procedure |
|
|
|
| Secondary | Mortality Calculated From Outcome Section From DPC Database at 30 Days | Posted | Number | participants | 30 days after the start of the procedure |
|
|
|
| 0 |
| 2,912 |
| 0 |
| 2,912 |
| EG001 | Enteral Nutrition | investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching | 0 | 2,912 | 0 | 2,912 |
Not provided
Not provided
| D010038 | Otorhinolaryngologic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |