Effect of Multimodal Prehabilitation on Clinical Outcomes in Patients With Tumor-Related Bowel Obstruction: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Comprehensive Complication Index (CCI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Expected survival ≥12 weeks;
- •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.
排除标准
- •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;
- •Long-term or high-dose use of immunosuppressants or glucocorticoids within 1 month before enrollment;
- •Presence of language communication barriers, unable to independently or with family assistance understand and complete intervention and assessment;
- •Patients currently participating in other drug or clinical interventional trials.
研究组 & 干预措施
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.
干预措施: Multimodal prehabilitation program (Behavioral)
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.
干预措施: Standard six-step treatment (Behavioral)
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.
干预措施: ERAS protocol (Behavioral)
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.
干预措施: Standard six-step treatment (Behavioral)
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.
干预措施: ERAS protocol (Behavioral)
结局指标
主要结局
Comprehensive Complication Index (CCI)
时间窗: 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).
次要结局
- mechanical ventilation time(POD 30（30 days after surgery）)
- The 30-day postoperative mortality(POD 30（30 days after surgery）)
- 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),)
- Preoperative and 30-day postoperative quality of life scores(Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）)
- Nutritional status-hemoglobin, albumin, prealbumin levels(Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30)
- Immune status - CRP, NLR, CD4/CD8(Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.)
- Functional capacity(Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）)
- postoperative ICU stay(POD 30（30 days after surgery）)
- The incidence and severity of complications within 30 days after the surgery(POD 30（30 days after surgery）)
- Preoperative and 30-day postoperative psychological states(Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）)
- postoperative pain severity(POD 30（30 days after surgery）)
- total hospitalization costs(POD 30（30 days after surgery）)