Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000
Qingdao, Shandong, 266003, China
NCT Number: NCT07767760
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Qingdao, Shandong, 266003, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
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.
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.
Time frame: 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).
Time frame: POD 30(30 days after surgery)
30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
Time frame: Baseline (T0), Post-intervention (At least 7 days),
The complication occurrence defined as complications diagnosed after admission and occurring before surgery
Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 30(30 days after surgery)
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 1, 3, 5, 30
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, and 30.
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 30(30 days after surgery)
preoperative and 30-day postoperative 6-Minute Walk Test
Time frame: POD 30(30 days after surgery)
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)
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: Baseline (T0), Post-intervention (at least 7 days), and POD 30(30 days after surgery)
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
Time frame: POD 30(30 days after surgery)
Time frame: POD 30(30 days after surgery)
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)
Contact information is provided by the study sponsor or research team.
The Affiliated Hospital of Qingdao University
Other
Effect of Multimodal Prehabilitation on Clinical Outcomes in Patients With Tumor-Related Bowel Obstruction: A Multicenter Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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