Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

NCT07767760 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Hospital of Qingdao University

Phase

Not applicable

Started

2026-08-01

Last updated

2026-08-17

Condition(s) studied

Malignant TumorPrehabilitation

Investigational drug(s) / intervention(s)

Multimodal prehabilitation programStandard six-step treatmentERAS protocol

Multimodal prehabilitation program: Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.

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.

ERAS protocol: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Comprehensive Complication Index (CCI) — 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).

Trial sites (1)

Facility	City	Region	Status
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000	Qingdao	Shandong

More The Affiliated Hospital of Qingdao University trials in China

Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer Recruiting

Safety and Efficacy of Small Extracellular Vesicles Nebulizer in Patients With Allergic Rhinitis Complicated With Asthma Starting soon

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy Starting soon

SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas Recruiting

Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer Starting soon

Other trials for the same condition

First-in-Human Study of the Radioligand 68Ga- DOTA-EphA2 Recruiting

Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease Recruiting

Home-based Whole Course Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health Starting soon

Psychological Distress in Malignant Tumor Patients: Effects on Treatment Adherence, Outcomes, and Quality of Life Recruiting

Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07767760 on ClinicalTrials.gov ↗ ← All trials in China