Malignant TumorNCT07767760
Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
A study testing Multimodal prehabilitation program, Standard six-step treatment and ERAS protocol in people with Malignant Tumor and Prehabilitation, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Tumor, Prehabilitation
- What is being tested?
- Multimodal prehabilitation program, Standard six-step treatment and ERAS protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000
Qingdao, Shandong, 266003
About this study
Official title: 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.
- Conditions
- Malignant Tumor, Prehabilitation
- Being tested
- Multimodal prehabilitation program, Standard six-step treatment, ERAS protocol
- Keywords
- Prehabilitation, Malignant tumor, Bowel Obstruction
- Medical subject headings
- Neoplasms, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitation programBehavioural
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
Standard six-step treatmentBehavioural
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 protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard six-step treatment; Behavioral: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative (≤30 days after surgery)
Secondary outcomes (12)
The 30-day postoperative mortality
30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
mechanical ventilation time
Measured: 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).
Measured: POD 30（30 days after surgery）
total hospitalization costs
Measured: POD 30（30 days after surgery）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Yantai Yuhuangding Hospital, Rizhao People's Hospital, Weifang People's Hospital, The Second Hospital of Shandong University, Fujian Medical University Union Hospital, Fudan University, Xinjiang Medical University, Peking University People's Hospital, The First School of Clinical Medicine of Binzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767760
- Sponsor's protocol ID
- GISSG-PREHAB2602
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes