Actively Recruiting
Antegrade Intestinal Fluid Reinfusion Versus Water Infusion Through Prophylactic Ileal Stoma for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial
Led by Pei-Rong Ding · Updated on 2026-04-17
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating if antegrade intestinal fluid reinfusion can prevent low anterior resection syndrome (LARS) in patients who have a prophylactic ileal stoma after low anterior resection surgery for rectal cancer. This study compares intestinal fluid reinfusion to water infusion to see which method is more effective in preventing LARS. It is a randomized controlled trial conducted at a single center and sponsored by Pei-Rong Ding. Participants will begin treatment one month after their anterior rectal resection with ileostomy surgery. They will receive either reinfusion of their own intestinal fluid diluted with warm saline or potable water through the distal end of the ileal stoma every other day until the ileostomy reversal surgery. Both groups receive instructions on enema procedures from an enterostomal therapist. During the study, participants will keep a diary of their symptoms. Researchers will assess outcomes including LARS scores and quality of life at multiple timepoints up to 12 months after ileostomy reversal. Safety and symptom monitoring will continue throughout the study period. Participation will last from one month post-surgery through at least one year after ileostomy reversal.
CONDITIONS
Brief Title
Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with mid to low rectal cancer (within 10cm of the anal verge) who undergo radical DIXON+ileostomy surgery
- General situation is well and one can take care of themselves
- Anal digital examination confirms that the anastomotic site has fully healed 1 month after surgery
- The anal sphincter function is good, and the ileostomy reverse surgery has not been completed
- Regardless of whether preoperative radiotherapy or chemotherapy has been received
You will not qualify if you...
- Patients with anastomotic leakage after rectal cancer surgery
- The patient's general physical condition is poor and they are unable to take care of themselves
- Expected inability to retract the stoma
- Patients with preoperative inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, etc.
- Inability to treat according to the plan, poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 4 weeks after surgery until ileostomy reversal surgery
Participants receive either intestinal fluid reinfusion or potable water infusion through the distal end of the ileal stoma every other day, starting from 4 weeks after surgery until the day before ileostomy reversal surgery.
Regular visits for enema procedure instruction and monitoring
Duration - Up to 12 months after ileostomy reversal surgery
Participants are monitored for bowel function and quality of life at multiple time points after ileostomy reversal surgery.
Visits at 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months after ileostomy reversal
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
P
Peirong Ding, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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