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Effects of Early Oral Feeding After Resection of Gastric Cancer

This study has been completed.
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00606619
First received: January 22, 2008
Last updated: May 27, 2010
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Other: Conventional feeding
Other: Early oral feeding
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Days of hospital stay after operation [ Time Frame: within 30 days after operation ] [ Designated as safety issue: No ]
    We measure the length of hospital stay after operation


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    We measure the days of flatus 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 ] [ Designated as safety issue: No ]
  • Symptom of Patients: Question to patients about symptoms [ Time Frame: before operation and 1,3,5,7 day after operation ] [ Designated as safety issue: No ]
  • Cost effectiveness: Total cost duration of hospitalization [ Time Frame: within 30 days after admission ] [ Designated as safety issue: No ]
    We measure total cost from admission to discharge after operation

  • Quality of life: EORTC QLQ30, STO22 [ Time Frame: 1,2 and 3 month after operation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol [ Time Frame: within 30 days after operation ] [ Designated as safety issue: Yes ]
    We observe the occurrence of morbidity after operation


Enrollment: 58
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606619

Locations
Korea, Republic of
St Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 150-713
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hae Myung Jeon, MD, Department of Surgery
ClinicalTrials.gov Identifier: NCT00606619     History of Changes
Other Study ID Numbers: SCMC07OT135
Study First Received: January 22, 2008
Last Updated: May 27, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by The Catholic University of Korea:
Gastrectomy
Oral feeding
Nutrition
Gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 25, 2014