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Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

14 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

394

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. 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;
  2. 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;
  3. Age between 18 and 85 years;
  4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  5. Expected survival ≥12 weeks;
  6. 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:

  1. Presence of acute, life-threatening complications such as strangulated bowel obstruction, electrolyte disturbances, or sepsis;
  2. Presence of intestinal necrosis, perforation, bleeding, or other conditions requiring immediate surgical treatment;
  3. 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);
  4. 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;
  5. Long-term or high-dose use of immunosuppressants or glucocorticoids within 1 month before enrollment;
  6. Presence of language communication barriers, unable to independently or with family assistance understand and complete intervention and assessment;
  7. Patients currently participating in other drug or clinical interventional trials.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: ERAS-protocol
De kerninhoud is het aannemen van een reeks geoptimaliseerde maatregelen die tijdens de perioperatieve periode worden uitgevoerd op basis van op bewijs gebaseerde medische bevindingen om de fysiologische en psychologische stress van patiënten te verminderen en hun herstel te versnellen.
Gedragsmatig: Multimodal prehabilitation program
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
Gedragsmatig: Standard six-step treatment
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.
Actieve vergelijker: 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.
Gedragsmatig: ERAS-protocol
De kerninhoud is het aannemen van een reeks geoptimaliseerde maatregelen die tijdens de perioperatieve periode worden uitgevoerd op basis van op bewijs gebaseerde medische bevindingen om de fysiologische en psychologische stress van patiënten te verminderen en hun herstel te versnellen.
Gedragsmatig: Standard six-step treatment
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Comprehensive Complication Index (CCI)
Tijdsspanne: Postoperative (≤30 days after surgery)
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).
Postoperative (≤30 days after surgery)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The 30-day postoperative mortality
Tijdsspanne: POD 30（30 days after surgery）
30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
POD 30（30 days after surgery）
Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment
Tijdsspanne: Baseline (T0), Post-intervention (At least 7 days),
The complication occurrence defined as complications diagnosed after admission and occurring before surgery
Baseline (T0), Post-intervention (At least 7 days),
Preoperative and 30-day postoperative quality of life scores
Tijdsspanne: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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.
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Nutritional status-hemoglobin, albumin, prealbumin levels
Tijdsspanne: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.
Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
Immune status - CRP, NLR, CD4/CD8
Tijdsspanne: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
Inflammatory indicators, including C-reactive protein (CRP), the neutrophil-to-lymphocyte ratio (NLR), and CD4/CD8, can reflect the level of inflammation.
Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
Functional capacity
Tijdsspanne: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
preoperative and 30-day postoperative 6-Minute Walk Test
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
postoperative ICU stay
Tijdsspanne: POD 30（30 days after surgery）
Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery.
POD 30（30 days after surgery）
The incidence and severity of complications within 30 days after the surgery
Tijdsspanne: POD 30（30 days after surgery）
Incidence and severity of complications within 30 days postoperatively (especially infectious complications) (all complications will be scored according to the Clavien-Dindo classification system)
POD 30（30 days after surgery）
Preoperative and 30-day postoperative psychological states
Tijdsspanne: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
mechanical ventilation time
Tijdsspanne: POD 30（30 days after surgery）
POD 30（30 days after surgery）
postoperative pain severity
Tijdsspanne: POD 30（30 days after surgery）
The severity of postoperative pain is evaluated using the Visual Analog Scale for pain (VAS, 0 = no pain, 10 = most severe pain).
POD 30（30 days after surgery）
total hospitalization costs
Tijdsspanne: POD 30（30 days after surgery）
POD 30（30 days after surgery）

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Affiliated Hospital of Qingdao University

Medewerkers

Peking University People's Hospital
Fudan University
Fujian Medical University Union Hospital
The Second Hospital of Shandong University
Yantai Yuhuangding Hospital
Xinjiang Medical University
Weifang People's Hospital
Rizhao People's Hospital
The First School of Clinical Medicine of Binzhou Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 augustus 2028

Studieregistratiedata

Eerst ingediend

11 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 augustus 2026

Eerst geplaatst (Werkelijk)

17 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

14 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GISSG-PREHAB2602

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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