Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
14. august 2026 oppdatert av: The Affiliated Hospital of Qingdao University
Effect of Multimodal Prehabilitation on Clinical Outcomes in Patients With Tumor-Related Bowel Obstruction: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to establish a multimodal prehabilitation protocol suitable for patients with tumor-related bowel obstruction during the perioperative period, and to explore its safety and efficacy; to evaluate the impact of this protocol on short-term and long-term clinical outcomes and recovery indicators.The participants will be divided into two groups.
The experimental group will receive an integrated program of preoperative multi-modal pre-rehabilitation intervention combined with postoperative immune nutrition support; the control group will receive traditional perioperative management for intestinal obstruction.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
394
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yanbing Zhou, MD
- Telefonnummer: 86532-82911324
- E-post: zhouyanbing@qduhospital.cn
Studiesteder
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Shandong
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Qingdao, Shandong, Kina, 266003
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Pathologically/cytologically confirmed malignant tumor (including digestive system and gynecological origin tumors); or imaging data suggesting tumor space-occupying lesions combined with multiple metastatic foci;
- Diagnosis of bowel obstruction (complete or incomplete) confirmed by medical history, symptoms, signs, and imaging (abdominal plain film/CT), and after MDT decision-making, no emergency surgery is required, short-term conservative treatment has potential for remission, and the expected interval from conservative treatment period to planned surgery is ≥7 days;
- Age between 18 and 85 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Expected survival ≥12 weeks;
- Patients and their families have full understanding of disease progression and prognosis, accept conservative treatment, and are fully mentally prepared for the high incidence of severe surgical complications; they can understand and voluntarily sign the written informed consent form, which must be signed before performing study-specified procedures.
Exclusion Criteria:
- Presence of acute, life-threatening complications such as strangulated bowel obstruction, electrolyte disturbances, or sepsis;
- Presence of intestinal necrosis, perforation, bleeding, or other conditions requiring immediate surgical treatment;
- ASA grade >IV, severe cardiac insufficiency (preoperative LVEF <30% or NYHA grade IV), severe hepatic dysfunction (Child-Pugh grade C), and renal dysfunction (requiring CRRT);
- History of cerebral hemorrhage, cerebral infarction, TIA, or presence of central nervous system disease, psychiatric disease, or bedridden status within 6 months before informed consent that precludes completion of multimodal intervention;
- Long-term or high-dose use of immunosuppressants or glucocorticoids within 1 month before enrollment;
- Presence of language communication barriers, unable to independently or with family assistance understand and complete intervention and assessment;
- Patients currently participating in other drug or clinical interventional trials.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Experimental group
The experimental group: on the basis of the standard six-step treatment model (decompression, adding nutrition, suppressing digestive fluid secretion, hormone, diuresis, and exercise and promoting intestinal peristalsis), a goal-directed multimodal prehabilitation intervention lasting 5 to 7 days will be superimposed and implemented during the preoperative hospitalization period, with contents including immunonutritional support, progressive physical training, and structured psychological counseling.
Postoperatively, the standard perioperative Enhanced Recovery After Surgery (ERAS) protocol will be continued to be executed, and immunonutritional treatment will be strengthened.
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Kjerneinnholdet er å ta i bruk en rekke optimaliserte tiltak utført i løpet av den perioperative perioden på grunnlag av evidensbaserte medisinske funn for å redusere det fysiologiske og psykologiske stresset til pasienter og for å akselerere deres restitusjon.
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
The standard six-step treatment protocol refers to: decompression, nutritional supplementation, suppression of digestive fluid secretion, hormone therapy, diuresis, exercise, and promotion of intestinal peristalsis.
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Aktiv komparator: Control group
The control group: preoperatively, only the standard six-step treatment protocol will be received.
Postoperatively, standard Enhanced Recovery After Surgery (ERAS) protocol will be followed for perioperative management.
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Kjerneinnholdet er å ta i bruk en rekke optimaliserte tiltak utført i løpet av den perioperative perioden på grunnlag av evidensbaserte medisinske funn for å redusere det fysiologiske og psykologiske stresset til pasienter og for å akselerere deres restitusjon.
The standard six-step treatment protocol refers to: decompression, nutritional supplementation, suppression of digestive fluid secretion, hormone therapy, diuresis, exercise, and promotion of intestinal peristalsis.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comprehensive Complication Index (CCI)
Tidsramme: Postoperative (≤30 days after surgery)
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Used to quantify the cumulative complication burden of individual patients.
The calculation premise is to first grade each complication occurring within 30 days postoperatively according to the Clavien-Dindo Classification (CDC), then accumulate the corresponding "weight (wC)" of each complication, substitute into the formula for square root calculation and divide by 2, ultimately obtaining a continuous score from 0-100 (0 = no complications, 100 = death).
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Postoperative (≤30 days after surgery)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The 30-day postoperative mortality
Tidsramme: POD 30（30 days after surgery）
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30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
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POD 30（30 days after surgery）
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Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment
Tidsramme: Baseline (T0), Post-intervention (At least 7 days),
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The complication occurrence defined as complications diagnosed after admission and occurring before surgery
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Baseline (T0), Post-intervention (At least 7 days),
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Preoperative and 30-day postoperative quality of life scores
Tidsramme: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
The questionnaire assesses 15 dimensions of HRQoL, including physical, psychological, and social functions.
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Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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Nutritional status-hemoglobin, albumin, prealbumin levels
Tidsramme: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
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Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.
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Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
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Immune status - CRP, NLR, CD4/CD8
Tidsramme: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
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Inflammatory indicators, including C-reactive protein (CRP), the neutrophil-to-lymphocyte ratio (NLR), and CD4/CD8, can reflect the level of inflammation.
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Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
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Functional capacity
Tidsramme: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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preoperative and 30-day postoperative 6-Minute Walk Test
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Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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postoperative ICU stay
Tidsramme: POD 30（30 days after surgery）
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Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery.
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POD 30（30 days after surgery）
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The incidence and severity of complications within 30 days after the surgery
Tidsramme: POD 30（30 days after surgery）
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Incidence and severity of complications within 30 days postoperatively (especially infectious complications) (all complications will be scored according to the Clavien-Dindo classification system)
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POD 30（30 days after surgery）
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Preoperative and 30-day postoperative psychological states
Tidsramme: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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Psychological states was measured by Hospital Anxiety and Depression Scale (HADS).
Higher scores indicate more severe anxiety or depression symptoms.
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Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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mechanical ventilation time
Tidsramme: POD 30（30 days after surgery）
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POD 30（30 days after surgery）
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postoperative pain severity
Tidsramme: POD 30（30 days after surgery）
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The severity of postoperative pain is evaluated using the Visual Analog Scale for pain (VAS, 0 = no pain, 10 = most severe pain).
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POD 30（30 days after surgery）
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total hospitalization costs
Tidsramme: POD 30（30 days after surgery）
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POD 30（30 days after surgery）
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. juli 2028
Studiet fullført (Antatt)
1. august 2028
Datoer for studieregistrering
Først innsendt
11. august 2026
Først innsendt som oppfylte QC-kriteriene
14. august 2026
Først lagt ut (Faktiske)
17. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GISSG-PREHAB2602
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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