Unique ID issued by UMIN | UMIN000031294 |
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Receipt number | R000035725 |
Scientific Title | Effects of differences in nutritional management after percutaneous endoscopic gastrostomy (PEG) on postoperative pneumonia: A retrospective analysis |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2018/12/19 14:40:31 |
Effects of differences in nutritional management after percutaneous endoscopic gastrostomy (PEG) on postoperative pneumonia: A retrospective analysis
Effects of nutritional management after PEG on pneumonia
Effects of differences in nutritional management after percutaneous endoscopic gastrostomy (PEG) on postoperative pneumonia: A retrospective analysis
Effects of nutritional management after PEG on pneumonia
Japan |
Patients who underwent PEG
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the effects of differences in postoperative nutritional management on incidence of pneumonia after PEG.
Safety
Exploratory
Pragmatic
Not applicable
Incidence of postoperative pneumonia (within 14 days after PEG)
(1) Incidence of leakage of nutritional formula from fistula (within 14 days after PEG)
(2) Incidence of fistula infection (within 14 days after PEG)
(3) Mortality rate (within 30 days after PEG)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients who underwent PEG in department of gastroenterology, Sapporo Kiyota Hospital from March 1999 to March 2014
(2) Patients aged 20 years or older
(1) Patients who were not received contrast radiography via the gastrostomy within 2 days after PEG
(2) Patients who underwent PEG in order to decompress stomach
350
1st name | |
Middle name | |
Last name | Tetsuro Okamoto |
Sapporo Kiyota Hospital
Department of Gastroenterology
1-1-1-1 Shinei, Kiyota-ku, Sapporo Hokkaido
011-883-6111
gofightersgo@gmail.com
1st name | |
Middle name | |
Last name | Satoru Kamoshita |
Otsuka Pharmaceutical Factory, Inc.
Applied Clinical Development Department
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
03-5217-5954
kamoshitas@otsuka.jp
Sapporo Kiyota Hospital
Otsuka Pharmaceutical Factory, Inc.
Profit organization
Japan
Rumoi Municipal Hospital
Otsuka Pharmaceutical Factory, Inc.
EN Otsuka Pharmaceutical Co., Ltd.
EN Otsuka Pharmaceutical Co., Ltd.
NO
札幌清田病院(北海道)
2018 | Year | 03 | Month | 01 | Day |
Published
Primary outcome
The incidence of postoperative pneumonia (within 14 days after PEG) was 20.8% (31/149) in period I, 7.8% (5/64) in period II and 10.2% (16/157) in period III. The odds ratio (95% confidence interval) of the event was 3.10 (1.15-8.38) for period I vs. II, 2.32 (1.21-4.44) for period I vs. III, 0.75 (0.26 - 2.13) for period II vs. III.
Secondary outcomes
The mortality rate (within 30 days after PEG) was 2.0% (3/149) in period I, 0.0% (0/64) in period II and 0.6% (1/157) in period III. The incidence of leakage of nutritional formula from fistula (within 14 days after PEG) was 6.0% (9/149) in period I, 1.6% (1/64) in period II and 1.9% (3/157) in period III. The incidence of fistula infection (within 14 days after PEG) was 28.2% (42/149) in period I, 17.2% (11/64) in period II and 20% (20/157) in period III.
Completed
2018 | Year | 01 | Month | 23 | Day |
2018 | Year | 01 | Month | 23 | Day |
2018 | Year | 04 | Month | 13 | Day |
Study design:
Single center retrospective observational study
Creation of dataset:
The data set should include patient backgrounds, postoperative complications and PEG-related adverse events collected from the medical record.
Study groups:
Patients are divided into three groups based on their treatment periods.
Period I (from March 1999 to June 2005): All patients received enteral formula after PEG.
Period II (from November 2005 to May 2007): Patients with gastroesophageal reflux revealed by contrast radiography via the gastrostomy after PEG received semi-solid enteral formula. Patients without gastroesophageal reflux revealed by contrast radiography via the gastrostomy after PEG received enteral formula.
Period III (from April 2010 to March 2014): All patients received semi-solid enteral formula after PEG.
Statistical analysis:
The incidence of postoperative pneumonia, leakage of nutritional formula, fistula infection, and mortality are compared between period I and II, I and III, and II and III. Logistic regression analysis is used to calculate odds ratio and 95% confidence interval.
2018 | Year | 02 | Month | 14 | Day |
2018 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035725
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