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Comparison of Outcomes Between Parenteral and Enteral Nutrition

NCT ID: NCT02512224

Last Updated: 2015-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5824 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.

Detailed Description

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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.

Conditions

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Deglutition Disorders

Keywords

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parenteral nutrition enteral nutrition

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type DEVICE

Participants are retrospectively selected with propensity score matching

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.

Enteral nutrition

Intervention Type DEVICE

Participants are retrospectively selected with propensity score matching

Interventions

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Parenteral nutrition

Participants are retrospectively selected with propensity score matching

Intervention Type DEVICE

Enteral nutrition

Participants are retrospectively selected with propensity score matching

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo University

OTHER

Sponsor Role lead

Responsible Party

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Sumito Ogawa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sumito Ogawa, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Tokyo University

References

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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.

Reference Type DERIVED
PMID: 26447149 (View on PubMed)

Other Identifiers

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MHLW H26-Special-047

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCGG 25-11

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MHLW H26-Policy-011

Identifier Type: -

Identifier Source: org_study_id