Deglutition Disorders
Conditions
Keywords
parenteral nutrition, enteral nutrition
Brief summary
Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.
Detailed description
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.
Interventions
DEVICEParenteral nutrition
Participants are retrospectively selected with propensity score matching
DEVICEEnteral nutrition
Participants are retrospectively selected with propensity score matching
Sponsors
Tokyo University
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* investigators selected participants aged 20 years or older who had undergone either parenteral nutrition by central venous port insertion or enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Patients who received both gastrostomy and central venous port insertion were assigned to the gastrostomy group.
Exclusion criteria
* investigators excluded participants who had been diagnosed with cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality Calculated From Outcome Section From DPC Database at 90 Days | 90 days after the start of the procedure |
Secondary
| Measure | 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. |
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2,912 |
| 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 | 2,912 |
| Total | 5,824 |
Baseline characteristics
| Characteristic | Enteral Nutrition | Parenteral Nutrition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2558 Participants | 2522 Participants | 5080 Participants |
| Age, Categorical Between 18 and 65 years | 354 Participants | 390 Participants | 744 Participants |
| Age, Continuous | 78.81 years STANDARD_DEVIATION 13.558 | 78.43 years STANDARD_DEVIATION 14.086 | 78.62 years STANDARD_DEVIATION 13.824 |
| Region of Enrollment Japan | 2912 participants | 2912 participants | 5824 participants |
| Sex: Female, Male Female | 1437 Participants | 1460 Participants | 2897 Participants |
| Sex: Female, Male Male | 1475 Participants | 1452 Participants | 2927 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2,912 | 0 / 2,912 |
| serious Total, serious adverse events | 0 / 2,912 | 0 / 2,912 |
Outcome results
Primary
Mortality Calculated From Outcome Section From DPC Database at 90 Days
Time frame: 90 days after the start of the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parenteral Nutrition | Mortality Calculated From Outcome Section From DPC Database at 90 Days | 359 Participants |
| Enteral Nutrition | Mortality Calculated From Outcome Section From DPC Database at 90 Days | 287 Participants |
Secondary
Mortality Calculated From Outcome Section From DPC Database at 14 Days
Time frame: 14 days after the start of the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parenteral Nutrition | Mortality Calculated From Outcome Section From DPC Database at 14 Days | 114 Participants |
| Enteral Nutrition | Mortality Calculated From Outcome Section From DPC Database at 14 Days | 89 Participants |
Secondary
Mortality Calculated From Outcome Section From DPC Database at 30 Days
Time frame: 30 days after the start of the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parenteral Nutrition | Mortality Calculated From Outcome Section From DPC Database at 30 Days | 114 participants |
| Enteral Nutrition | Mortality Calculated From Outcome Section From DPC Database at 30 Days | 89 participants |
Secondary
Post-procedural Pneumonia
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parenteral Nutrition | Post-procedural Pneumonia | 346 Participants |
| Enteral Nutrition | Post-procedural Pneumonia | 450 Participants |
Secondary
Post-procedural Sepsis
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parenteral Nutrition | Post-procedural Sepsis | 129 Participants |
| Enteral Nutrition | Post-procedural Sepsis | 108 Participants |
Secondary
Re-admission 30 Days
Time frame: re-admission within 30 days of discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parenteral Nutrition | Re-admission 30 Days | 188 Participants |
| Enteral Nutrition | Re-admission 30 Days | 159 Participants |