- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Seoul, Korea, Republiken av, 150-713
- St Mary's Hospital, The Catholic University of Korea
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: 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.
|
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.
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Days of hospital stay after operation
Tidsram: within 30 days after operation
|
We measure the length of hospital stay after operation
|
within 30 days after operation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: within 30 days after operation
|
We measure the days of flatus within 30 days after operation
|
within 30 days after operation
|
Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured
Tidsram: 1,3,5 and 7 day after operation
|
1,3,5 and 7 day after operation
|
|
Symptom of Patients: Question to patients about symptoms
Tidsram: before operation and 1,3,5,7 day after operation
|
before operation and 1,3,5,7 day after operation
|
|
Cost effectiveness: Total cost duration of hospitalization
Tidsram: within 30 days after admission
|
We measure total cost from admission to discharge after operation
|
within 30 days after admission
|
Quality of life: EORTC QLQ30, STO22
Tidsram: 1,2 and 3 month after operation
|
1,2 and 3 month after operation
|
|
Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
Tidsram: before operation and 1,3,5,7 day after operation
|
before operation and 1,3,5,7 day after operation
|
|
Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
Tidsram: within 30 days after operation
|
We observe the occurrence of morbidity after operation
|
within 30 days after operation
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Hae Myung Jeon, MD, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
- Studierektor: Hoon Hur, MD, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SCMC07OT135
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Magcancer
-
Universitätsklinikum Hamburg-EppendorfCentre Hospitalier Universitaire de Nice; Olympus Corporation; Keio University och andra samarbetspartnersAvslutadGastric Focal LesionFrankrike
-
RSP Systems A/SAvslutad
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AvslutadRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal sleeve gastrectomy | Magbandning | Bypass, GastricFörenta staterna
-
State University of New York - Upstate Medical...AvslutadGastric Bypass StatusFörenta staterna
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IndragenGastric Bypass-kirurgi
-
Medtronic - MITGAvslutad
-
Wageningen UniversityRijnstate HospitalOkändRoux-en-Y Gastric BypassNederländerna
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAvslutadRoux en Y Gastric BypassFörenta staterna
-
DuomedAktiv, inte rekryterandeFetma | Gastrektomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
-
Olympus Corporation of the AmericasUnity Health TorontoAvslutad
Kliniska prövningar på Conventional feeding
-
Inonu UniversityHar inte rekryterat ännuStroke | Motoriska bilder | Action Observation Training | Graderade motorbilderKalkon
-
Emory UniversityChildren's Healthcare of AtlantaAvslutadMatnings- och ätstörningar | Undvikande/restriktivt matintagsstörning | MatningsstörningarFörenta staterna
-
University Hospital, AngersOkändMaternell fetmaFrankrike
-
University of MalayaAvslutad