Effects of Early Oral Feeding After Resection of Gastric Cancer

• ClinicalTrials.gov Identifier: NCT00606619
• Recruitment Status: Completed
• First Posted: February 4, 2008
• Last Update Posted: May 28, 2010
• Sponsor: The Catholic University of Korea
• Information provided by: The Catholic University of Korea

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Other: Conventional feeding; Other: Early oral feeding	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
• Study Start Date: July 2008
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: February 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Days of hospital stay after operation [ Time Frame: within 30 days after operation ]
   We measure the length of hospital stay after operation

Secondary Outcome Measures :

1. 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
2. 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 ]
3. Symptom of Patients: Question to patients about symptoms [ Time Frame: before operation and 1,3,5,7 day after operation ]
4. Cost effectiveness: Total cost duration of hospitalization [ Time Frame: within 30 days after admission ]
   We measure total cost from admission to discharge after operation
5. Quality of life: EORTC QLQ30, STO22 [ Time Frame: 1,2 and 3 month after operation ]
6. 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 ]
7. 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hae Myung Jeon, MD, Department of Surgery
• ClinicalTrials.gov Identifier: NCT00606619
• Other Study ID Numbers: SCMC07OT135
• First Posted: February 4, 2008
• Last Update Posted: May 28, 2010
• Last Verified: February 2009

Keywords provided by The Catholic University of Korea:

Gastrectomy; Oral feeding; Nutrition; Gastric cancer

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases