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Completed

NCT Number: NCT00606619

Effects of Early Oral Feeding After Resection of Gastric Cancer

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Mary's Hospital, The Catholic University of Korea

Seoul, 150-713, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Days of hospital stay after operation

    Time frame: within 30 days after operation

    We measure the length of hospital stay after operation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 4, 2008
Registry last updated
May 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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