An interventional study of Multimodal prehabilitation program and Standard six-step treatment in Malignant Tumor and Prehabilitation, sponsored by The Affiliated Hospital of Qingdao University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 394 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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)
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）
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),
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）
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, 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
mechanical ventilation time
Time frame: 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).
Time frame: POD 30（30 days after surgery）
total hospitalization costs
Time frame: POD 30（30 days after surgery）
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jul 2028, 23 months later.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 23 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University →