RecruitingPhase 2Phase 3NCT07537998

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

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.


Sponsor

Pei-Rong Ding

Enrollment

160 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

COMBINATION_PRODUCTintestinal fluid infusion

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

COMBINATION_PRODUCTpotable water

Infuse potable water through the distal end of the stoma.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07537998


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