The goal of this clinical trial is to learn if antegrade intestinal fluid reinfusion works to prevent low anterior resection syndrome (LARS) in patients with prophylactic ileal stoma. The main questions it aims to answer are:
1. Does it work to prevent LARS by antegrade intestinal fluid reinfusion before performing the ileostomy reversal surgery? 2. Is antegrade intestinal fluid reinfusion more effective than water infusion in preventing LARS.
Participants will:
1. Receive either antegrade intestinal fluid reinfusion or antegrade water infusion through ileal stoma based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.
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 ilestomy reverse surgery has not been completed.
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.
Parallel
intestinal fluid infusion
Combination productPrepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma.
potable water
Combination productInfuse potable water through the distal end of the stoma.
LARS score(m1)
Improvement in LARS score 1 month after ileostomy reversal surgery between the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).
Major LARS rate(m1)
Major LARS rate 1 month after ileostomy reversal
LARS score (m0-12)
Trajectory of change of LARS score after ileostomy reversal surgery in the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).
MSKCC BFI
Memorial Sloan Kettering Cancer Centre Bowel Function Instrument
Wexner score
The Wexner scoring system is a clinical tool used to assess the severity of constipation. Mainly used to quantify the constipation symptoms of patients and their impact on their quality of life. Including five aspects: defecation frequency, difficulty in defecation, emptying sensation, abdominal pain, and time spent in the toilet. The total score range is 0-25 points. A score below 7 points is considered mild constipation, 7-15 points is moderate constipation, and above 15 points is severe constipation.
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Pei-Rong Ding
Lead sponsor
Sun Yat-sen University
Sponsor institution
