Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

14 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

394

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

Studieorter

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

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

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

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: 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.
Beteende: ERAS-protokoll
Kärninnehållet är att anta en serie optimerade åtgärder som utförs under den perioperativa perioden på basis av evidensbaserade medicinska fynd för att minska den fysiologiska och psykologiska stressen hos patienter och för att påskynda deras återhämtning.
Beteende: Multimodal prehabilitation program
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
Beteende: 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.
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.
Beteende: ERAS-protokoll
Kärninnehållet är att anta en serie optimerade åtgärder som utförs under den perioperativa perioden på basis av evidensbaserade medicinska fynd för att minska den fysiologiska och psykologiska stressen hos patienter och för att påskynda deras återhämtning.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Comprehensive Complication Index (CCI)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The 30-day postoperative mortality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: POD 30（30 days after surgery）
POD 30（30 days after surgery）
postoperative pain severity
Tidsram: 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
Tidsram: POD 30（30 days after surgery）
POD 30（30 days after surgery）

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Affiliated Hospital of Qingdao University

Samarbetspartners

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

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 (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 juli 2028

Avslutad studie (Beräknad)

1 augusti 2028

Studieregistreringsdatum

Först inskickad

11 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

14 augusti 2026

Första postat (Faktisk)

17 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GISSG-PREHAB2602

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera