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NCT07767760
Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
Conditions: Malignant Tumor, Prehabilitation
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 394
Sponsor: The Affiliated Hospital of Qingdao University
Location: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000 Qingdao Shandong
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07767760). StuddyBuddy aggregates publicly available trial information.