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Effects of Early Oral Feeding After Resection of Gastric Cancer
This study is currently recruiting participants.
Verified by The Catholic University of Korea, July 2008
Sponsored by: The Catholic University of Korea
Information provided by: The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT00606619
  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 III

MedlinePlus related topics: Cancer Stomach Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer

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

Primary Outcome Measures:
  • Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol [ Time Frame: within hospitalization after operation ] [ Designated as safety issue: Yes ]
  • Days of hospital stay after operation [ Time Frame: within hospitalization after operation ] [ Designated as safety issue: No ]

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: during hospital stay ] [ Designated as safety issue: No ]
  • 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: at the discharge time ] [ Designated as safety issue: No ]
  • 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 ]

Estimated Enrollment: 58
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Conventional feeding
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.
2: Experimental
Early oral feeding
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606619

Contacts
Contact: Hoon Hur, MD +82-2-3472-6320 hhcmc75@naver.com

Locations
Korea, Republic of
St Mary's Hospital, The Catholic University of Korea Recruiting
Seoul, Korea, Republic of, 150-713
Contact: Hoon Hur, MD     +82-2-3472-6320     hhcmc75@naver.com    
Contact: Hae Myung Jeon, MD     +82-2-3779-2020     hmjeon@catholic.ac.kr    
Principal Investigator: Hae Myung Jeon, MD, PhD            
Sub-Investigator: Hoon Hur, MD            
Sub-Investigator: Sung Bae Jee, MD            
Sub-Investigator: Dong Jae Kim, PhD            
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

Clinical Research Coordinating Center, College of Medicine, The Catholic University of Korea  This link exits the ClinicalTrials.gov site
St.Mary's Hospital, College of Medicine, The Catholic University of Korea  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Department of Surgery ( Hae Myung Jeon, MD )
Study ID Numbers: SCMC07OT135
Study First Received: January 22, 2008
Last Updated: July 30, 2008
ClinicalTrials.gov Identifier: NCT00606619  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009