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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPei-Rong Ding

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • intestinal fluid infusion
  • potable water

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Pei-Rong Ding

Lead sponsor

Sun Yat-sen University

Sponsor institution