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Effects of Early Oral Feeding After Resection of Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Conventional feeding
Early oral feeding
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastrectomy, Oral feeding, Nutrition, Gastric cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • St Mary's Hospital, The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Days of hospital stay after operation
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
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
Symptom of Patients: Question to patients about symptoms
Cost effectiveness: Total cost duration of hospitalization
We measure total cost from admission to discharge after operation
Quality of life: EORTC QLQ30, STO22
Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
We observe the occurrence of morbidity after operation

Full Information

First Posted
January 22, 2008
Last Updated
May 27, 2010
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00606619
Brief Title
Effects of Early Oral Feeding After Resection of Gastric Cancer
Official Title
Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastrectomy, Oral feeding, Nutrition, Gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm 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.
Arm Title
2
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Conventional feeding
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Early oral feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days of hospital stay after operation
Description
We measure the length of hospital stay after operation
Time Frame
within 30 days after operation
Secondary Outcome Measure Information:
Title
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
Description
We measure the days of flatus within 30 days after operation
Time Frame
within 30 days after operation
Title
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
Title
Symptom of Patients: Question to patients about symptoms
Time Frame
before operation and 1,3,5,7 day after operation
Title
Cost effectiveness: Total cost duration of hospitalization
Description
We measure total cost from admission to discharge after operation
Time Frame
within 30 days after admission
Title
Quality of life: EORTC QLQ30, STO22
Time Frame
1,2 and 3 month after operation
Title
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
Title
Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
Description
We observe the occurrence of morbidity after operation
Time Frame
within 30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria: Performed curative resection Have The American Society of Anaesthesiologists (ASA) score of less than 3 Exclusion Criteria: Patients who have simultaneously other cancer. Patients who underwent gastric resection at past time. Patients who have cancer with bleeding or perforation or obstruction. Patients who have any injury to the pancreas capsule on operation. Patients who get pregnancy. Patients who are treating diabetics with Insulin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae Myung Jeon, MD
Organizational Affiliation
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hoon Hur, MD
Organizational Affiliation
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Official's Role
Study Director
Facility Information:
Facility Name
St Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15532842
Citation
Suehiro T, Matsumata T, Shikada Y, Sugimachi K. Accelerated rehabilitation with early postoperative oral feeding following gastrectomy. Hepatogastroenterology. 2004 Nov-Dec;51(60):1852-5.
Results Reference
background
PubMed Identifier
15946413
Citation
Gabor S, Renner H, Matzi V, Ratzenhofer B, Lindenmann J, Sankin O, Pinter H, Maier A, Smolle J, Smolle-Juttner FM. Early enteral feeding compared with parenteral nutrition after oesophageal or oesophagogastric resection and reconstruction. Br J Nutr. 2005 Apr;93(4):509-13. doi: 10.1079/bjn20041383.
Results Reference
background
PubMed Identifier
7618972
Citation
Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
Results Reference
background
PubMed Identifier
19399550
Citation
Hur H, Si Y, Kang WK, Kim W, Jeon HM. Effects of early oral feeding on surgical outcomes and recovery after curative surgery for gastric cancer: pilot study results. World J Surg. 2009 Jul;33(7):1454-8. doi: 10.1007/s00268-009-0009-3.
Results Reference
derived

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Effects of Early Oral Feeding After Resection of Gastric Cancer

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