Effects of Early Oral Feeding After Resection of Gastric Cancer

May 27, 2010 updated by: The Catholic University of Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 150-713
        • St Mary's Hospital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of hospital stay after operation
Time Frame: within 30 days after operation
We measure the length of hospital stay after operation
within 30 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
within 30 days after admission
Quality of life: EORTC QLQ30, STO22
Time Frame: 1,2 and 3 month after operation
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
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
within 30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMC07OT135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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