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Recruiting Phase 2/3

Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.

NCT07537998 · tracked via the Priya Life Science China tracker
Sponsor
Pei-Rong Ding
Phase
Phase 2/3
Started
2026-04-10
Last updated
2026-04-17

Condition(s) studied

Low Anterior Resection SyndromeRectal Cancer

Investigational drug(s) / intervention(s)

intestinal fluid infusionpotable water

intestinal fluid infusion: Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma.

potable water: Infuse potable water through the distal end of the stoma.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07537998 on ClinicalTrials.gov ↗ ← All trials in China