Radiation intestinal injury
Conditions
Interventions
Intervention group and control group:Home oral nutritional supplementation (ONS) +Routine guidance on diet and exercise
Control group:Routine guidance on diet and exercise
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: After CRE, 142 patients were screened positive for NRS2002 (1) Age 18-70 years old; (2) Previous pathological diagnosis of pelvic tumor (gynecology, prostate, urinary system); (3) History of pelvic radiotherapy, at least 6 months after the end of the last radiotherapy; (4) No recurrence or metastasis of the primary tumor; (5) ECOG score of whole body function status is 0-2 points; (6) Serum albumin =30g/L during screening; (7) CRE complicated with late complications such as intestinal obstruction, intestinal fistula, etc., need a first stage resection of the diseased intestine; (8) The subjects and their family members can understand the study protocol and are willing to participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Emergency surgery; (2) Patients who only underwent adhesion release or enterostomy without resection of the diseased bowel; (3) The primary tumor is unstable or combined with tumors at other sites; (4) Patients requiring combined organ resection; (5) Patients who still need to use parenteral nutrition 1 week after surgery. (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; (7) Active infection or severe liver, kidney, endocrine, respiratory, neurological, cardiovascular diseases; (8) serious mental illness; (9) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal muscle mass index; | — |
Secondary
| Measure | Time frame |
|---|---|
| grip;Stride speed; | — |
Countries
China
Contacts
Public ContactYan Ting
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed