Low Anterior Resection Syndrome, Rectal Cancer
Conditions
Keywords
low anterior resection syndrome, antegrade intestinal fluid reinfusion
Brief summary
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.
Interventions
COMBINATION_PRODUCTintestinal fluid infusion
Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma.
COMBINATION_PRODUCTpotable water
Infuse potable water through the distal end of the stoma.
Sponsors
Pei-Rong Ding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Regardless of whether preoperative radiotherapy or chemotherapy has been received.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LARS score(m1) | 1 month after ileostomy reversal surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major LARS rate(m1) | 1 month after ileostomy reversal | Major LARS rate 1 month after ileostomy reversal |
| LARS score (m0-12) | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery | 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 | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery | Memorial Sloan Kettering Cancer Centre Bowel Function Instrument |
| Wexner score | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery | 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. |
| quality of life for rectal cancer patients | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery | quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 ) |
Countries
China
Contacts
CONTACTPeirong Ding, M.D
Outcome results
None listed