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Sponsored by: |
The Catholic University of Korea |
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Information provided by: | The Catholic University of Korea |
ClinicalTrials.gov Identifier: | NCT00606619 |
The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
Condition | Intervention | Phase |
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Gastric Cancer |
Other: Conventional feeding Other: Early oral feeding |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer |
Estimated Enrollment: | 58 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Conventional feeding
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Other: Conventional feeding
Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.
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2: Experimental
Early oral feeding
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Other: Early oral feeding
Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.
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Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:
Exclusion Criteria:
Contact: Hoon Hur, MD | +82-2-3472-6320 | hhcmc75@naver.com |
Korea, Republic of | |
St Mary's Hospital, The Catholic University of Korea | Recruiting |
Seoul, Korea, Republic of, 150-713 | |
Contact: Hoon Hur, MD +82-2-3472-6320 hhcmc75@naver.com | |
Contact: Hae Myung Jeon, MD +82-2-3779-2020 hmjeon@catholic.ac.kr | |
Principal Investigator: Hae Myung Jeon, MD, PhD | |
Sub-Investigator: Hoon Hur, MD | |
Sub-Investigator: Sung Bae Jee, MD | |
Sub-Investigator: Dong Jae Kim, PhD |
Principal Investigator: | Hae Myung Jeon, MD | Department of Surgery, St Mary's Hospital, The Catholic University of Korea |
Study Director: | Hoon Hur, MD | Department of Surgery, St Mary's Hospital, The Catholic University of Korea |
Responsible Party: | Department of Surgery ( Hae Myung Jeon, MD ) |
Study ID Numbers: | SCMC07OT135 |
Study First Received: | January 22, 2008 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00606619 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Gastrectomy Oral feeding Nutrition Gastric cancer |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site |