Postopertive condition of Endoscopic Submucosal Dissection
Conditions
Interventions
Pre-habilitation Group:Patients randomly assigned to the preoperative rehabilitation group will receive a structured preoperative rehabilitation intervention for 4 weeks before endoscopic submucosal d
Control Group:Patients in the control group will receive standard preoperative education and routine nursing measures routinely provided by our hospital for patients with endoscopic submucosal dissect
Sponsors
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients undergoing ESD: >=18 years of age, scheduled to undergo elective endoscopic submucosal dissection (ESD) for lesions in the upper or lower digestive tract (e.g., early gastric cancer, colon polyps, early colorectal tumors, or esophageal lesions). ESD indications need to be confirmed by the endoscopic or surgical team (for example, the size and histological type of the lesion meet ESD criteria, and preoperative examination does not show signs of deep infiltration or metastasis of the lesion). Adequate pre-operative preparation time: Patients had surgery at least 4 weeks prior to enrollment to ensure sufficient time to implement the 4-week pre-operative rehabilitation intervention. This means that patients receive ESD as elective surgery and can safely wait several weeks for preoperative preparation. Exercise capacity: Patient's functional status at baseline allows for light to moderate intensity exercise training. This does not mean that patients must have a good exercise foundation, in fact, patients with lower than average fitness level are more suitable for the target population of this study, but patients should have basic walking ability and the ability to perform simple physical activities (even if the current endurance is poor). For example, patients were required to be able to climb a flight of stairs or walk at least one block (allowed to continue after rest) in order to participate in the study. A simple functional assessment tool, such as the Duke Activity State Index [DASI] questionnaire or the 6-minute walking test, will be used to assess baseline motor capacity to ensure that patients are able to participate in exercise training. Informed consent: Patients voluntarily participate in the study, are able to understand the study randomization requirements and agree to receive randomized outcomes (preoperative rehabilitation intervention or standard care), and are able to cooperate with the study process and sign a written informed consent.
Exclusion criteria
Exclusion criteria: Patients in need of emergency or emergency ESD: patients with an urgent condition who cannot wait 4 weeks for preoperative rehabilitation intervention (for example, the presence of a rapidly progressing malignancy is highly suspected and requires immediate surgical intervention, although this is less common in early stage lesions). All cases in which a delay in ESD surgery could pose a serious health risk to the patient were excluded. Severe comorbidities, not suitable for exercise intervention: There is a serious medical disease or health problem that prevents the patient from safely or effectively participating in exercise training. Examples include unstable cardiovascular disease (such as uncontrolled angina, recent myocardial infarction, severe aortic stenosis), uncontrolled congestive heart failure, severe chronic obstructive pulmonary disease (COPD) that prevents exercise, or uncontrolled high blood pressure. In addition, patients with severe musculoskeletal or neurological conditions that prevent them from walking (such as being wheelchair-dependent and unable to complete specified training movements) are not included. If necessary, the patient will undergo a pre-exercise medical assessment to confirm safety. Cognitive or psychiatric impairment: Patients with significant cognitive impairment, dementia, or serious mental illness (e.g., uncontrolled psychosis, major depressive disorder) that interferes with daily functioning and prevents them from participating in structured intervention programs or from reliably following training instructions or completing research questionnaires. The patient should have normal communication skills and be able to communicate effectively with the trainer. Patients currently participating in structured preoperative rehabilitation or exercise training: Patients who had participated in other formal preoperative rehabilitation programs or high-intensity exercise training programs, or who had recently completed similar programs, were excluded to prevent cross-contamination of the effects of the study intervention. In addition, patients with exceptional physical fitness and regular training habits (such as competitive athletes) were not included, because the additional benefit of preoperative rehabilitation intervention in this study may be small for these patients (although this situation is not common in conventional ESD patients). People with other uncontrolled medical conditions: Patients with other uncontrolled conditions that may significantly interfere with interventions or study outcomes, such as active infections or fever, or patients with end-stage conditions with a life expectancy of less than 6 months. Patients receiving palliative care pathways or requiring other major surgical interventions (such as other surgical procedures) at the same time will also be excluded to ensure that the intervention effects of ESD and preoperative rehabilitation are evaluated without interference from other factors. Pregnant patients: Due to the possible unknown risks of high-intensity exercise to pregnancy, and ESD itself is a special situation during pregnancy, pregnant patients were not included in the study. For women with a possibility of pregnancy, pregnancy will be routinely asked before surgery and pregnancy testing may be performed according to standard care procedures. In general, pregnant patients usually postpone ESD surgery unless absolutely necessary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minutes walk test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Complications;Length of Hospital Stay;Number of Re-hospitalization;EuroQol five dimensions questionnaire, EQ-5D-5L;Hospital axiety and depression score;cost of intervention; | — |
Countries
China
Contacts
Public ContactJiang Biyun
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed