Effects of Early Oral Feeding After Resection of Gastric Cancer
|Gastric Cancer||Other: Conventional feeding Other: Early oral feeding||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer|
- Days of hospital stay after operation [ Time Frame: within 30 days after operation ]We measure the length of hospital stay after operation
- Day of recovery of bowel sound and flatus: Evidence of recovery of bowel sound by physician's examination and Evidence of first flatus by question to patient [ Time Frame: within 30 days after operation ]We measure the days of flatus within 30 days after operation
- Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured [ Time Frame: 1,3,5 and 7 day after operation ]
- Symptom of Patients: Question to patients about symptoms [ Time Frame: before operation and 1,3,5,7 day after operation ]
- Cost effectiveness: Total cost duration of hospitalization [ Time Frame: within 30 days after admission ]We measure total cost from admission to discharge after operation
- Quality of life: EORTC QLQ30, STO22 [ Time Frame: 1,2 and 3 month after operation ]
- Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA [ Time Frame: before operation and 1,3,5,7 day after operation ]
- Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol [ Time Frame: within 30 days after operation ]We observe the occurrence of morbidity after operation
|Study Start Date:||July 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
No Intervention: 1
Conventional feeding : They begin ingesting sips of water on third postoperative day and continued with a liquid diet for the next two days. Patients were given a soft diet on sixth postoperative day.
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.
Early oral feeding : The patients begin ingesting sips of water on the first postoperative day. If they are tolerable, they continued with a clear liquid diet the next day and a soft diet on the third post operative day.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606619
|Korea, Republic of|
|St Mary's Hospital, The Catholic University of Korea|
|Seoul, Korea, Republic of, 150-713|
|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|