Prospective, randomized controlled clinical study of home oral nutritional supplementation (ONS) for nutritional support after chronic radiation intestinal injury
- Conditions
- Radiation intestinal injury
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
After CRE, 142 patients were screened positive for NRS2002<br>(1) Age 18-70 years old;<br>(2) Previous pathological diagnosis of pelvic tumor (gynecology, prostate, urinary system);<br>(3) History of pelvic radiotherapy, at least 6 months after the end of the last radiotherapy;<br>(4) No recurrence or metastasis of the primary tumor;<br>(5) ECOG score of whole body function status is 0-2 points;<br>(6) Serum albumin =30g/L during screening;<br>(7) CRE complicated with late complications such as intestinal obstruction, intestinal fistula, etc., need a first stage resection of the diseased intestine;<br>(8) The subjects and their family members can understand the study protocol and are willing to participate and sign the informed consent.
(1) Emergency surgery;<br>(2) Patients who only underwent adhesion release or enterostomy without resection of the diseased bowel;<br>(3) The primary tumor is unstable or combined with tumors at other sites;<br>(4) Patients requiring combined organ resection;<br>(5) Patients who still need to use parenteral nutrition 1 week after surgery.<br>(6) Subjects with contraindications to enteral nutrition (e.g., active gastrointestinal bleeding, intestinal obstruction, decompensated short bowel syndrome (ileocecal valve, small intestine length =100cm, no ileocecal valve) Small intestine length =150cm) [30], high-flow intestinal fistula, severe intra peritoneal infection, severe gastrointestinal obstruction, unstable vital signs, abnormal coagulation, severe nausea, vomiting, and/or uncontrolled diarrhea/steatorrhea), and the above symptoms are deemed by the investigator to be uncorrected; Or are known to be allergic to any of the pharmaceutical ingredients in enteral nutrition preparations or have a more severe allergy;<br>(7) Active infection or severe liver, kidney, endocrine, respiratory, neurological, cardiovascular diseases;<br>(8) serious mental illness;<br>(9) Pregnant or lactating women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skeletal muscle mass index;
- Secondary Outcome Measures
Name Time Method grip;Stride speed;