Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

N/ANot Yet RecruitingNCT07767760

The Affiliated Hospital of Qingdao University394 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

394

Conditions

Malignant Tumor Prehabilitation

Interventions

Standard six-step treatmentBEHAVIORAL

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 protocolBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Comprehensive Complication Index (CCI)

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).

Time frame: Postoperative (≤30 days after surgery)

Secondary Outcomes

The 30-day postoperative mortality

30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.

Time frame: POD 30（30 days after surgery）

Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment

The complication occurrence defined as complications diagnosed after admission and occurring before surgery

Time frame: Baseline (T0), Post-intervention (At least 7 days),

Preoperative and 30-day postoperative quality of life scores

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.

Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）

Nutritional status-hemoglobin, albumin, prealbumin levels

Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.

Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30

Immune status - CRP, NLR, CD4/CD8

Inflammatory indicators, including C-reactive protein (CRP), the neutrophil-to-lymphocyte ratio (NLR), and CD4/CD8, can reflect the level of inflammation.

Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.

Functional capacity

preoperative and 30-day postoperative 6-Minute Walk Test

Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）

postoperative ICU stay

Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery.

Time frame: POD 30（30 days after surgery）

The incidence and severity of complications within 30 days after the 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)

Time frame: POD 30（30 days after surgery）

Preoperative and 30-day postoperative psychological states

Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.

Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）

mechanical ventilation time

Time frame: POD 30（30 days after surgery）

postoperative pain severity

The severity of postoperative pain is evaluated using the Visual Analog Scale for pain (VAS, 0 = no pain, 10 = most severe pain).

Time frame: POD 30（30 days after surgery）

total hospitalization costs

Time frame: POD 30（30 days after surgery）

Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts