Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Affiliated Hospital of Qingdao University
About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Multimodal prehabilitation program
- Standard six-step treatment
- ERAS protocol
Treatment groups
394 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor
Yantai Yuhuangding Hospital
Collaborator
Rizhao People's Hospital
Collaborator
Weifang People's Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Fudan University
Collaborator
Xinjiang Medical University
Collaborator
Peking University People's Hospital
Collaborator
The First School of Clinical Medicine of Binzhou Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov