- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00606619
Effects of Early Oral Feeding After Resection of Gastric Cancer
Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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-
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Seoul, 대한민국, 150-713
- St Mary's Hospital, The Catholic University of Korea
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: 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.
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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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Days of hospital stay after operation
기간: within 30 days after operation
|
We measure the length of hospital stay after operation
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within 30 days after operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
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
기간: within 30 days after operation
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We measure the days of flatus within 30 days after operation
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within 30 days after operation
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Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured
기간: 1,3,5 and 7 day after operation
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1,3,5 and 7 day after operation
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Symptom of Patients: Question to patients about symptoms
기간: before operation and 1,3,5,7 day after operation
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before operation and 1,3,5,7 day after operation
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Cost effectiveness: Total cost duration of hospitalization
기간: within 30 days after admission
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We measure total cost from admission to discharge after operation
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within 30 days after admission
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Quality of life: EORTC QLQ30, STO22
기간: 1,2 and 3 month after operation
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1,2 and 3 month after operation
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Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
기간: before operation and 1,3,5,7 day after operation
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before operation and 1,3,5,7 day after operation
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Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
기간: within 30 days after operation
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We observe the occurrence of morbidity after operation
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within 30 days after operation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hae Myung Jeon, MD, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
- 연구 책임자: Hoon Hur, MD, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
간행물 및 유용한 링크
일반 간행물
- 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.
- 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-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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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