Effects of Early Oral Feeding After Resection of Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606619
• Other study ID #: SCMC07OT135
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2008
• Last updated: May 27, 2010
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	St Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Gabor S, Renner H, Matzi V, Ratzenhofer B, Lindenmann J, Sankin O, Pinter H, Maier A, Smolle J, Smolle-Jüttner FM. Early enteral feeding compared with parenteral nutrition after oesophageal or oesophagogastric resection and reconstruction. Br J Nutr. 2005 Apr;93(4):509-13. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of hospital stay after operation	We measure the length of hospital stay after operation	within 30 days after operation	No
Secondary	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	within 30 days after operation	No
Secondary	Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured		1,3,5 and 7 day after operation	No
Secondary	Symptom of Patients: Question to patients about symptoms		before operation and 1,3,5,7 day after operation	No
Secondary	Cost effectiveness: Total cost duration of hospitalization	We measure total cost from admission to discharge after operation	within 30 days after admission	No
Secondary	Quality of life: EORTC QLQ30, STO22		1,2 and 3 month after operation	No
Secondary	Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA		before operation and 1,3,5,7 day after operation	No
Secondary	Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol	We observe the occurrence of morbidity after operation	within 30 days after operation	Yes

External Links

•   Clinical Research Coordinating Center, College of Medicine, The Catholic University of Korea