Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Affiliated Hospital of Qingdao University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal prehabilitation program
BehavioralMultimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
Standard six-step treatment
BehavioralThe 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 protocol
BehavioralThe 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.
Treatment groups
394 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 3 interventions
Group B: Control groupActive comparator 2 interventions
Trial outcomes
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).
Time frame
Postoperative (≤30 days after surgery)Secondary outcomes
1
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）2
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),3
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）4
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, 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Affiliated Hospital of Qingdao University
Lead sponsor
Yantai Yuhuangding Hospital
Collaborator
Rizhao People's Hospital
Collaborator
Weifang People's Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Fudan University
Collaborator
Xinjiang Medical University
Collaborator
Peking University People's Hospital
Collaborator
The First School of Clinical Medicine of Binzhou Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov
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