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Effects of Early Oral Feeding After Resection of Gastric Cancer

Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00606619
Enrollment
58
Registered
2008-02-04
Start date
2008-07-31
Completion date
2009-02-28
Last updated
2010-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastrectomy, Oral feeding, Nutrition, Gastric cancer

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.

Interventions

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.

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.

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria: 1. Performed curative resection 2. Have The American Society of Anaesthesiologists (ASA) score of less than 3

Exclusion criteria

1. Patients who have simultaneously other cancer. 2. Patients who underwent gastric resection at past time. 3. Patients who have cancer with bleeding or perforation or obstruction. 4. Patients who have any injury to the pancreas capsule on operation. 5. Patients who get pregnancy. 6. Patients who are treating diabetics with Insulin.

Design outcomes

Primary

MeasureTime frameDescription
Days of hospital stay after operationwithin 30 days after operationWe measure the length of hospital stay after operation

Secondary

MeasureTime frameDescription
Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured1,3,5 and 7 day after operation
Symptom of Patients: Question to patients about symptomsbefore operation and 1,3,5,7 day after operation
Cost effectiveness: Total cost duration of hospitalizationwithin 30 days after admissionWe measure total cost from admission to discharge 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 patientwithin 30 days after operationWe measure the days of flatus within 30 days after operation
Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISAbefore operation and 1,3,5,7 day after operation
Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocolwithin 30 days after operationWe observe the occurrence of morbidity after operation
Quality of life: EORTC QLQ30, STO221,2 and 3 month after operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026