Malignant Tumor, Prehabilitation
Conditions
Keywords
Prehabilitation, Malignant tumor, Bowel Obstruction
Brief 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.
Interventions
BEHAVIORALMultimodal prehabilitation program
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
BEHAVIORALStandard 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.
BEHAVIORALERAS 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.
Sponsors
The Affiliated Hospital of Qingdao University
Yantai Yuhuangding Hospital
Rizhao People's Hospital
Weifang People's Hospital
The Second Hospital of Shandong University
Fujian Medical University Union Hospital
Fudan University
Xinjiang Medical University
Peking University People's Hospital
The First School of Clinical Medicine of Binzhou Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 30-day postoperative mortality | POD 30（30 days after surgery） | 30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization. |
| Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment | Baseline (T0), Post-intervention (At least 7 days), | The complication occurrence defined as complications diagnosed after admission and occurring before surgery |
| Preoperative and 30-day postoperative quality of life scores | 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. |
| Nutritional status-hemoglobin, albumin, prealbumin levels | 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. |
| Immune status - CRP, NLR, CD4/CD8 | 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. |
| Functional capacity | Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery） | preoperative and 30-day postoperative 6-Minute Walk Test |
| postoperative ICU stay | POD 30（30 days after surgery） | Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery. |
| The incidence and severity of complications within 30 days after the surgery | 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) |
| Preoperative and 30-day postoperative psychological states | 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. |
| mechanical ventilation time | POD 30（30 days after surgery） | — |
| postoperative pain severity | 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). |
| total hospitalization costs | POD 30（30 days after surgery） | — |
Countries
China
Contacts
CONTACTYanbing Zhou, MD
Outcome results
None listed