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Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Förväntat)

368

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • Shandong
      • Qingdao, Shandong, Kina, 266000
        • Rekrytering
        • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år till 85 år (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Aged 65-85 years;
  2. Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  3. G8 score ≤14;
  4. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
  5. Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
  6. Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
  7. Date of surgery ≥2 weeks from baseline (T0) assessment;
  8. Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
  9. 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:

  1. Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
  2. 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;
  3. Cerebral bleeding or infarction (within 6 months);
  4. Patients with recurrent infection diseases or serious concomitant disease;
  5. Patients who require synchronous surgery due to other illness;
  6. Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
  7. Patients who are participating in any other clinical trials.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The incidence and severity of postoperative complications
Tidsram: 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.
Postoperative (≤30 days after surgery)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cardio-pulmonary function and physical capacity
Tidsram: 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.
Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
Quality of life (QoL).
Tidsram: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
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.
Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
Detection of immune and inflammatory indicators
Tidsram: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations
Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
The postoperative other observation parameters
Tidsram: Postoperative (≤30 days after surgery)
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.
Postoperative (≤30 days after surgery)
Oncological outcomes
Tidsram: 3 years
3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.
3 years

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 maj 2022

Primärt slutförande (Förväntat)

1 maj 2023

Avslutad studie (Förväntat)

1 maj 2026

Studieregistreringsdatum

Först inskickad

18 april 2022

Först inskickad som uppfyllde QC-kriterierna

24 april 2022

Första postat (Faktisk)

29 april 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 april 2022

Senast verifierad

1 april 2022

Mer information

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