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


Phase 3
20 Years
75 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Days of hospital stay after operation

Outcome Description:

We measure the length of hospital stay after operation

Outcome Time Frame:

within 30 days after operation

Safety Issue:

No

Principal Investigator

Hae Myung Jeon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, St Mary's Hospital, The Catholic University of Korea

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

SCMC07OT135

NCT ID:

NCT00606619

Start Date:

July 2008

Completion Date:

February 2009

Related Keywords:

  • Gastric Cancer
  • Gastrectomy
  • Oral feeding
  • Nutrition
  • Gastric cancer
  • Stomach Neoplasms

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