Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Days of hospital stay after operation
We measure the length of hospital stay after operation
within 30 days after operation
No
Hae Myung Jeon, MD
Principal Investigator
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
South Korea: Korea Food and Drug Administration (KFDA)
SCMC07OT135
NCT00606619
July 2008
February 2009
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