Unique ID issued by UMIN | UMIN000021056 |
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Receipt number | R000024297 |
Scientific Title | Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction |
Date of disclosure of the study information | 2016/02/16 |
Last modified on | 2017/02/03 11:20:00 |
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Japan |
Esophageal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the effectiveness of oligomeric formula for postoperative diarrhea and nutritional status
Efficacy
Frequency of diarrhea and fecal condition (Bristol stool form scale)
Successful rate of administration of nutrients(7 postoperative days)
Postoperative complications, Nutrition status (Rapid turnover protein, weight change), Laboratory evidence, Length of stay in intensive care unit, Postoperative hospital stay, Tube obstruction
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine | Food |
Oligomeric formula
Administration period:
Until postoperative day 7
Dosage:
Start at 10ml/h
10ml/h increase every day
Polymeric formula
Administration period:
Until postoperative day 7
Dosage:
Start at 10ml/h
10ml/h increase every day
20 | years-old | <= |
Not applicable |
Male and Female
Esophageal cancer patients underwent esophagectomy and enterostomy
Reconstruction methods: Gastric tube reconstruction
Written informed consent.
Pt. without enterostomy
Pt. without gastric tube reconstruction
Pt. with a history of digestive surgery (except appendectomy)
Pt. with colon or other digestive surgery simultaneously
Pt. with an allergic of milk or soy or gelatin including nutrients
Pt. with a tendency for loose stool (at 6 times or more of defecation per day)
No informed consent is obtained
64
1st name | |
Middle name | |
Last name | Harushi Udagawa |
Toranomon hospital
Department of Gastroenterological Surgery
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan.
03-3588-1111
udagawah@toranomon.gr.jp
1st name | |
Middle name | |
Last name | Yu Ohkura |
Toranomon hospital
Department of Gastroenterological Surgery
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan.
03-3588-1111
yu.ohkura107@gmail.com
Department of Gastroenterological Surgery, Toranomon Hospital
Department of Gastroenterological Surgery, Toranomon Hospital
Self funding
NO
2016 | Year | 02 | Month | 16 | Day |
Unpublished
Open public recruiting
2016 | Year | 01 | Month | 19 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 02 | Month | 16 | Day |
2017 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024297
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