Combined Oral and Parenteral Nutritional Therapy After Gastrectomy for Gastric Cancer (BRIDGE-GC)
Bridging the Postoperative Nutritional Gap After Gastrectomy for Gastric Cancer: A Prospective Randomized Trial of Combined Oral and Parenteral Nutritional Therapy
Patients undergoing gastrectomy for gastric cancer frequently experience insufficient oral intake during the postoperative recovery period because of reduced gastric capacity, early satiety, and gastrointestinal symptoms. Although oral nutritional supplements (ONS) are commonly recommended, adherence is often poor, resulting in a postoperative nutritional gap.
This prospective randomized clinical trial was designed to evaluate the impact of combined oral and parenteral nutritional therapy on nutritional status and recovery after gastrectomy for gastric cancer. Patients were randomized to either a combined nutritional therapy group receiving oral nutritional supplementation plus parenteral nutrition or a control group receiving standard postoperative care.
The primary endpoint was postoperative body weight change at 4 weeks after surgery. Secondary endpoints included body composition, nutritional intake, inflammatory and immune markers, laboratory parameters, and quality of life outcomes.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Postoperative nutritional deterioration remains a major clinical challenge after gastrectomy for gastric cancer. Reduced gastric capacity and postoperative gastrointestinal symptoms frequently result in inadequate oral intake during the early recovery period. Although oral nutritional supplements are widely recommended, adherence is often poor, potentially leading to insufficient caloric intake and postoperative nutritional deficits.
This prospective randomized clinical trial evaluates whether combined oral and parenteral nutritional therapy can improve postoperative nutritional status and recovery compared with standard postoperative care. Patients undergoing curative gastrectomy for gastric cancer are randomized to receive either combined oral nutritional supplementation plus parenteral nutrition or standard postoperative nutritional management.
Nutritional outcomes including body weight, body mass index, body composition, inflammatory markers, laboratory nutritional parameters, caloric intake, oral nutritional supplement adherence, and quality of life are assessed during the postoperative recovery period.
This study aims to clarify the clinical significance of supplemental parenteral nutrition in bridging the postoperative nutritional gap after gastrectomy.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Seoul
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Seoul, Seoul, Sør -Korea, 06591
- Seoul St. Mary'S Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age 20 to 80 years
- Histologically confirmed gastric cancer
- Scheduled for curative total or subtotal gastrectomy
- Ability to tolerate oral intake
- Residence within areas covered by home care services
- Written informed consent
Exclusion Criteria:
- Body mass index (BMI) ≥30 kg/m² or <18.5 kg/m²
- Uncontrolled diabetes mellitus
- Severe hepatic or renal dysfunction
- Active malignancy other than gastric cancer
- Previous chemotherapy or radiotherapy
- Allergy to oral nutritional supplement products
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Combined Nutritional Therapy
Patients received combined oral nutritional supplementation and parenteral nutritional support during the postoperative recovery period after gastrectomy for gastric cancer.
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Patients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer.
Supplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements.
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Aktiv komparator: Standard Postoperative Care
Patients received standard postoperative nutritional management according to institutional clinical pathways after gastrectomy for gastric cancer.
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Standard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Body Weight Change
Tidsramme: 4 weeks after surgery
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Difference between preoperative body weight and body weight measured at 4 weeks after gastrectomy for gastric cancer.
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4 weeks after surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Body Mass Index Change
Tidsramme: 4 weeks after surgery
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4 weeks after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tegn og symptomer, fordøyelseskanal
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Neoplasmer i magen
- Hyperfagi
- Terapeutikk
- Mat
- Kosthold, mat og ernæring
- Fysiologiske fenomener
- Mat og drikke
- Ernæringsterapi
- Fôringsmetoder
- Ernæringsstøtte
- Kosttilskudd
- Parenteral ernæring
Andre studie-ID-numre
- XC17MCDI0065
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