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Recruiting Phase 2/3 NCT07537998

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

Phase 2/3 – combined trial
Conditions: Low Anterior Resection Syndrome Rectal Cancer

Sponsor: Pei-Rong Ding

trial.available_in: БГ
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.
Who can participate
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.
Interventions
intestinal fluid infusion
COMBINATION_PRODUCT
potable water
COMBINATION_PRODUCT
Locations 1
China (1)
Sun Yat-sen University Cancer Center
Guangzhou , Guangdong
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
10.04.2026
Completion date
10.04.2028
Registry ID
NCT07537998
Source
clinicaltrials.gov
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