Effects of Early Oral Feeding After Resection of Gastric Cancer

NCT00606619 | Completed Phase 3

• 1 other identifier: SCMC07OT135
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastrectomy; Oral feeding; Nutrition; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Days of hospital stay after operation

  We measure the length of hospital stay after operation

  within 30 days after operation

Secondary Outcomes (7)

• 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

  within 30 days after operation

• 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

• Symptom of Patients: Question to patients about symptoms

  before operation and 1,3,5,7 day after operation

• Cost effectiveness: Total cost duration of hospitalization

  within 30 days after admission

• Quality of life: EORTC QLQ30, STO22

  1,2 and 3 month after operation

Study Arms (2)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Interventions

Conventional feeding OTHER

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.

1

Early oral feeding OTHER

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.

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

St Mary's Hospital, The Catholic University of Korea

Seoul, 150-713, South Korea

Location

Related Publications (4)

• 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.

  PMID: 15532842 BACKGROUND

• 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.

  PMID: 15946413 BACKGROUND

• 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.

  PMID: 7618972 BACKGROUND

• 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.

  PMID: 19399550 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hae Myung Jeon, MD

  Department of Surgery, St Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Hoon Hur, MD

  Department of Surgery, St Mary's Hospital, The Catholic University of Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 4, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 28, 2010

Record last verified: 2009-02

Locations

KR (1)