- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05352802
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
24. april 2022 opdateret af: The Affiliated Hospital of Qingdao University
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer: A Multicenter Randomized Controlled Trial
The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG).
The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
368
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yanbing Zhou, MD
- Telefonnummer: 86532-82911324
- E-mail: zhouyanbing@qduhospital.cn
Undersøgelse Kontakt Backup
- Navn: Yuqi Sun, MD
- Telefonnummer: 86532-82911324
- E-mail: 2021010097@qdu.edu.cn
Studiesteder
-
-
Shandong
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Qingdao, Shandong, Kina, 266000
- Rekruttering
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
-
Kontakt:
- Yanbing Zhou, MD
- Telefonnummer: 86532-82911324
- E-mail: zhouyanbing@qduhospital.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 85 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Aged 65-85 years;
- Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- G8 score ≤14;
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
- Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
- Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
- Date of surgery ≥2 weeks from baseline (T0) assessment;
- Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
- All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.
Exclusion Criteria:
- Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
- Cerebral bleeding or infarction (within 6 months);
- Patients with recurrent infection diseases or serious concomitant disease;
- Patients who require synchronous surgery due to other illness;
- Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
- Patients who are participating in any other clinical trials.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Prehabilitation group
The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.
|
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
|
Aktiv komparator: ERAS group
The ERAS group patients were treated according to the ERAS pathway.
|
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The incidence and severity of postoperative complications
Tidsramme: Postoperative (≤30 days after surgery)
|
Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications.
The severity of complications was recorded and classified according to Clavien-Dindo classification score.
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Postoperative (≤30 days after surgery)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cardio-pulmonary function and physical capacity
Tidsramme: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.
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Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
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Quality of life (QoL).
Tidsramme: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
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QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status.
Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status.
Each index score ranges from 1 to 4, with higher scores indicating higher risk.
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Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
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Detection of immune and inflammatory indicators
Tidsramme: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
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Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations
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Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
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The postoperative other observation parameters
Tidsramme: Postoperative (≤30 days after surgery)
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Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.
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Postoperative (≤30 days after surgery)
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Oncological outcomes
Tidsramme: 3 years
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3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.
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3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studieleder: Yanbing Zhou, MD, The Affiliated Hospital of Qingdao University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. maj 2022
Primær færdiggørelse (Forventet)
1. maj 2023
Studieafslutning (Forventet)
1. maj 2026
Datoer for studieregistrering
Først indsendt
18. april 2022
Først indsendt, der opfyldte QC-kriterier
24. april 2022
Først opslået (Faktiske)
29. april 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GISSG+2201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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