Phase 2 Trial for Intestinal Fluid Reinfusion Prevention of Low Anterior Resection Syndrome
Summary
NIH registered a Phase 2 clinical trial (NCT07537998) on ClinicalTrials.gov to evaluate antegrade intestinal fluid reinfusion for prevention of low anterior resection syndrome in patients with prophylactic ileal stoma. The single-center, prospective randomized controlled trial will compare intestinal fluid infusion to potable water infusion in approximately 60 participants. Participants will receive the assigned intervention at 1 month post-rectal resection until ileostomy reversal and maintain symptom diaries.
What changed
This ClinicalTrials.gov registration documents a new Phase 2 clinical trial investigating antegrade intestinal fluid reinfusion as a prophylactic intervention against low anterior resection syndrome following low anterior rectal resection with protective ileostomy. The trial will enroll participants who will be randomized to receive either intestinal fluid reinfusion or potable water infusion through the ileal stoma during the interval between rectal resection and ileostomy reversal. Participants must maintain symptom diaries throughout the study period.
For clinical investigators and healthcare providers conducting or considering similar research, this registration signals continued interest in gastrointestinal reconstructive techniques and functional outcome optimization following rectal cancer surgery. Trial sponsors and institutional review boards should ensure compliance with all applicable clinical research regulations and Good Clinical Practice standards.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
Phase 2 NCT07537998 Kind: PHASE2 Apr 17, 2026
Abstract
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:
- Does it work to prevent LARS by antegrade intestinal fluid reinfusion before performing the ileostomy reversal surgery?
- Is antegrade intestinal fluid reinfusion more effective than water infusion in preventing LARS.
Participants will:
- 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.
- Keep a diary of their symptoms.
Conditions: Low Anterior Resection Syndrome, Rectal Cancer
Interventions: intestinal fluid infusion, potable water
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