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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van, 150-713
- St Mary's Hospital, The Catholic University of Korea
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Days of hospital stay after operation
Tijdsspanne: within 30 days after operation
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We measure the length of hospital stay after operation
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within 30 days after operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Hae Myung Jeon, MD, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
- Studie directeur: Hoon Hur, MD, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SCMC07OT135
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