Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

Effect of Multimodal Prehabilitation on Clinical Outcomes in Patients With Tumor-Related Bowel Obstruction: A Multicenter Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Tumor; Prehabilitation
• Intervention / Treatment: Behavioral: ERAS protocol; Behavioral: Multimodal prehabilitation program; Behavioral: Standard six-step treatment

• Study Type: Interventional
• Enrollment (Estimated): 394
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanbing Zhou, MD; Phone Number: 86532-82911324; Email: zhouyanbing@qduhospital.cn

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: ERAS 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.; Behavioral: Multimodal prehabilitation program; Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.; Behavioral: Standard 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.
Active Comparator: 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.	Behavioral: ERAS 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.; Behavioral: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Postoperative (≤30 days after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 30-day postoperative mortality	30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.	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	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.	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.	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.	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	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.	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)	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.	Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
mechanical ventilation time		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).	POD 30（30 days after surgery）
total hospitalization costs		POD 30（30 days after surgery）

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Collaborators: Peking University People's Hospital; Fudan University; Fujian Medical University Union Hospital; The Second Hospital of Shandong University; Yantai Yuhuangding Hospital; Xinjiang Medical University; Weifang People's Hospital; Rizhao 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 record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 14, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Prehabilitation; Malignant tumor; Bowel Obstruction
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms; Intestinal Obstruction
• Other Study ID Numbers: GISSG-PREHAB2602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No