Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT07537998

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

Led by Pei-Rong Ding · Updated on 2026-04-17

160

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 ileostomy reverse surgery has not been completed.
  • Regardless of whether preoperative radiotherapy or chemotherapy has been received.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

P

Peirong Ding, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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