Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Days of hospital stay after operation
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:
- •Performed curative resection
- •Have The American Society of Anaesthesiologists (ASA) score of less than 3
Exclusion Criteria
- •Patients who have simultaneously other cancer.
- •Patients who underwent gastric resection at past time.
- •Patients who have cancer with bleeding or perforation or obstruction.
- •Patients who have any injury to the pancreas capsule on operation.
- •Patients who get pregnancy.
- •Patients who are treating diabetics with Insulin.
Arms & Interventions
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.
Intervention: Conventional feeding (Other)
2
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.
Intervention: Early oral feeding (Other)
Outcomes
Primary Outcomes
Days of hospital stay after operation
Time Frame: within 30 days after operation
We measure the length of hospital stay after operation
Secondary Outcomes
- 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(within 30 days after operation)
- Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured(1,3,5 and 7 day after operation)
- Symptom of Patients: Question to patients about symptoms(before operation and 1,3,5,7 day after operation)
- Cost effectiveness: Total cost duration of hospitalization(within 30 days after admission)
- Quality of life: EORTC QLQ30, STO22(1,2 and 3 month after operation)
- Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA(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(within 30 days after operation)