Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

NCT07767760 | Not Yet Recruiting DMC

• 1 other identifier: GISSG-PREHAB2602
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor; Prehabilitation

Keywords

Prehabilitation; Malignant tumor; Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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.

Study Arms (2)

Experimental group

EXPERIMENTAL

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: Multimodal prehabilitation program; Behavioral: Standard six-step treatment; Behavioral: ERAS protocol

Control group

ACTIVE COMPARATOR

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: Standard six-step treatment; Behavioral: ERAS protocol

Interventions

Multimodal prehabilitation program BEHAVIORAL

Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.

Experimental group

Standard six-step treatment BEHAVIORAL

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.

Control group; Experimental group

ERAS protocol BEHAVIORAL

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: collaborator
• Weifang People's Hospital: collaborator
• The Second Hospital of Shandong University: collaborator
• Fudan University: collaborator
• Peking University People's Hospital: collaborator
• The Affiliated Hospital of Qingdao University: lead
• Rizhao People's Hospital: collaborator
• Fujian Medical University Union Hospital: collaborator
• Xinjiang Medical University: collaborator
• The First School of Clinical Medicine of Binzhou Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Neoplasms; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Yanbing Zhou, MD

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)