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

Sponsor
Pei-Rong Ding
Study ID
NCT07537998
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • intestinal fluid infusion — COMBINATION_PRODUCT
    Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma.
  • potable water — COMBINATION_PRODUCT
    Infuse potable water through the distal end of the stoma.

Study Details

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.

Key Dates

First listed
Apr 17, 2026
Start date
Apr 10, 2026
Status verified
Nov 2025
Primary completion
Apr 10, 2027
Completion
Apr 10, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intestinal fluid reinfusion
    Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study. After preparing the autologous intestinal fluid, it is diluted with warm saline to a volume of 200-500 ml. It is then returned through the distal end of the ileal stoma in a retrograde manner, once every other day.
  • Active Comparator: Water infusion
    Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study. Prepare 200-500 ml of potable water, and then infuse it antegradely from the distal end of the ileal stoma, once every other day.

Primary Outcome Measure

LARS score(m1) [ Time Frame: 1 month after ileostomy reversal surgery ]

Central Contacts

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