Registration of various associations and foundations by the Ministry of Civil Affairs
Conditions
Interventions
Experimental group:Tube feeding whole enteral nutrition (EEN), EN starts to pump from 20ml/h, the patient tolerates it well to 40ml/h on the 2nd day, 60ml/h on the 3rd day, and slowly adjusts it up to
Control group:The EEN method is the same as before. Treatment with ustekinumab is added and the drug is used according to the standard course of drug treatment
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with confirmed Crohn’s disease (CD) or highly suspected CD who require surgical intervention; 2.Situations requiring surgical intervention: (1) Intestinal stricture causing obvious obstruction; (2) Intestinal perforation with enteric fistula formation; (3) Intra-abdominal abscess
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiovascular, hepatic, renal, hematologic diseases, or malignancies. 2. Intestinal obstruction, enteric fistula, or intra-abdominal abscess not caused by Crohn’s disease. 3. Poor compliance or inability/unwillingness to follow the study protocol. 4. Pregnant or breastfeeding women. 5. Patients with severe primary cardiac, hepatic, pulmonary, renal, hematologic, or other serious diseases that may affect survival. 6. Patients who, due to intellectual or behavioral disorders, are unable to provide fully informed consent. 7. Patients with suspected or confirmed history of alcohol or drug abuse. 8. Other conditions which, in the investigator’s opinion, may reduce the likelihood of enrollment or complicate participation, such as unstable work or living conditions that may easily lead to loss to follow-up. 9. Patients with an allergic constitution, such as a history of allergy to two or more drugs or foods, or known allergy to any component of the study medication. 10. Patients currently participating in another clinical trial involving investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-term complications;Long-term complications;Harvey-Bradshaw index;Small intestine MRE;Abdominal ulteasound;Nutritional Risk Screening 2002;Simple Endoscopic Score for Crohn’s Disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative nutritional status;CD disease activity;1-year CD recurrence; | — |
Countries
China
Contacts
Public ContactYang Bolin
Affiliated Hospital of Nanjing University of Chinese Medicine
Outcome results
None listed