NCT07537998

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.

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Pei-Rong Ding · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Anterior Resection Syndrome
• Rectal Cancer

Interventions

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

Timeline

• Start date: 2026-04-10
• Primary completion: 2027-04-10
• Completion: 2028-04-10
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China