Gut Dysfunction after Ileostomy Closure
Conditions
Interventions
Control Group:Normal saline (100 mL), administered via colostomy for retrograde enema, once weekly
Trial Group:Probiotics (6 capsules of bifidobacterium trilactis enteric-coated capsules dissolved in 100 mL normal saline), administered via colostomy for retrograde enema, once weekly
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Patients undergoing their first radical resection of rectal cancer (Dixon procedure) with prophylactic double-barrel ileostomy for mid-to-low rectal cancer at our hospital; 3. Planned readmission for elective prophylactic ileostomy closure; 4. At least 12 weeks have passed since the initial stoma creation; 5. Patency of the distal intestinal lumen (a 14Fr urinary catheter can be inserted >= 15 cm without resistance); 6. Conscious, with basic communication and reading skills, able to understand the study content and cooperate with the intervention and follow-up; voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of malignant tumors in other sites, or recurrence or metastasis of colorectal cancer; 2. Severe cardiac, pulmonary, hepatic, or renal dysfunction, or other severe primary systemic diseases that may render the patient unable to tolerate the enema intervention or the second surgery; 3. History of chronic intestinal diseases such as active inflammatory bowel disease or intestinal tuberculosis; 4. Local factors affecting the intervention, such as severe stoma complications, distal intestinal obstruction, stricture, or recurrence; 5. Known allergy to any component of the study probiotic, or concurrent participation in other interventional clinical trials; 6. Any condition that, in the investigator's judgment, may prevent the patient from completing the study procedures and data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first flatus after surgery;Time to first bowel movement after surgery;Safety outcomes (including mild discomfort [mild bloating, mild abdominal pain, transient redness of stoma mucosa], moderate discomfort [worsening abdominal pain, focal bleeding from stoma mucosa], severe discomfort [severe abdominal pain, persistent bleeding from stoma mucosa]); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of early postoperative complications;Length of hospital stay;Total hospitalization cost;Patient satisfaction;Low Anterior Resection Syndrome (LARS) score; | — |
Countries
China
Contacts
Public ContactYu Fang
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed