- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01697943
Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy (GCQOL02)
A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Roux-En-Y Pouch Reconstruction and Conventional Roux-En-Y Reconstruction in Patients Undergoing Total Gastrectomy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down.
Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed.
This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
-
Kontakt:
- Ya Nong Wang, MD,PhD
- Telefonnummer: 1208 +86-21 64175590
- E-mail: huahuang@fudan.edu.cn
-
Kontakt:
- Hua Huang, MD,PhD
- Telefonnummer: 1205 +86-21 64175590
- E-mail: huahuang@fudan.edu.cn
-
Ledende efterforsker:
- Ya Nong Wang, MD,PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
• Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.
- Patients 20-75 years old
- Normal organ function, able to tolerate surgery, no clear contraindication for surgery
- No evidence of metastases of adjacent organs
- be able to provide follow-up over 2 years
- No specific treatment for gastric cancer before surgery
- In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
- The subjects were able to understand and comply with the trial protocol, and signed informed consent.
Exclusion Criteria:
• Synchronous or metachronous (less than five years) and with other malignancies.
- Cirrhosis and portal hypertension
- Associated with blood diseases
- Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
- Suffering from a serious neurological diseases or psychological diseases affecting the life
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in QOL (Quality of Life)
Tidsramme: 5years
|
From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
|
5years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Patienters ernæringstilstand
Tidsramme: 5 år
|
5 år
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-44-563
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Kliniske forsøg med Gastrisk Tumor
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Medtronic - MITGAfsluttet
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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DuomedAktiv, ikke rekrutterendeFedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
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Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
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North Dakota State UniversityNational Institutes of Health (NIH)AfsluttetRoux en Y Gastric Bypass OperationForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Wageningen UniversityRijnstate HospitalUkendtRoux-en-Y Gastric BypassHolland
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttet
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetSleeve Gastrectomy | Roux en Y Gastric BypassForenede Stater
Kliniske forsøg med Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
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West China HospitalUkendtLivskvalitet | Mavekræft | Komplikation | Roux-en-y Anastomosis Site | Gastrisk anastomose (sted)Kina
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The First Affiliated Hospital with Nanjing Medical...Ukendt
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Nanfang Hospital of Southern Medical UniversityUkendtNeoplasmer i maven | Minimalt invasiv kirurgi | AnastomoseKina
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Jilin UniversityUkendt
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Gangnam Severance HospitalAfsluttetMavekræft | Diabetes mellitus type 2 hos NonobeseKorea, Republikken
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University Hospital, LilleMinistry of Health, FranceRekrutteringDiabetes mellitus type 2 hos overvægtigeFrankrig
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CARLOS ZERRWECK LOPEZAfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Metabolisk kirurgiMexico
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TingBo LiangUkendtHepatolithiasis | Sphincter of Oddi LaxityKina
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Kyungpook National University Chilgok HospitalAfsluttetDiabetes mellitus, type 2 | Neoplasma i mavenKorea, Republikken
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Marco BueterDr. Alan Spector, Florida State University, Department of PsychologyAfsluttetFedme | Bariatrisk kirurgi | Indtagelsesadfærd | Madmangel | Roux-en-y Gastric Bypass | Indtagsmikrostruktur | DrikkemålerSchweiz