Effects of Early Oral Feeding After Resection of Gastric Cancer

The Catholic University of Korea

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Other: Early oral feeding; Other: Conventional feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT00606619

SCMC07OT135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

1

No Intervention group

Description:

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.

Treatment:

Other: Conventional feeding

2

Experimental group

Description:

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.

Treatment:

Other: Early oral feeding