Clinical trial NCT00606619: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastrectomy
Oral feeding
Nutrition
Gastric cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Days of hospital stay after operation
timeFrame: within 30 days after operation
Secondary outcomes:
measure: 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
timeFrame: within 30 days after operation
measure: Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured
timeFrame: 1,3,5 and 7 day after operation
measure: Symptom of Patients: Question to patients about symptoms
timeFrame: before operation and 1,3,5,7 day after operation
measure: Cost effectiveness: Total cost duration of hospitalization
timeFrame: within 30 days after admission
measure: Quality of life: EORTC QLQ30, STO22
timeFrame: 1,2 and 3 month after operation
measure: Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
timeFrame: before operation and 1,3,5,7 day after operation
measure: Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
timeFrame: within 30 days after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: St Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Department of Surgery, St Mary's Hospital, The Catholic University of Korea
name: Hae Myung Jeon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, St Mary's Hospital, The Catholic University of Korea
name: Hoon Hur, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.