Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intestinal fluid infusion, potable water.
- Who it may be relevant to
- Registry conditions: Low Anterior Resection Syndrome, Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antegrade Intestinal Fluid Reinfusion Verse Water Infusion Through Prophylactic Ileal Stoma for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
Overview
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 product intestinal fluid infusion
Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma. - Combination product potable water
Infuse potable water through the distal end of the stoma.
Primary outcome measures
- LARS score(m1) [Time frame: 1 month after ileostomy reversal surgery]
Secondary outcome measures (5)
- Major LARS rate(m1) [Time frame: 1 month after ileostomy reversal]
- LARS score (m0-12) [Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery]
- MSKCC BFI [Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery]
- Wexner score [Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery]
- quality of life for rectal cancer patients [Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07537998 · 2025-FXY-438