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.

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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome; Rectal Cancer
• Intervention / Treatment: Combination product: intestinal fluid infusion; Combination product: potable water

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Peirong Ding, M.D; Phone Number: 86-020-87343920; Email: dingpr@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Peirong Ding, M.D; Phone Number: 86-020-87343920; Email: dingpr@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intestinal fluid reinfusion; Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study. After preparing the autologous intestinal fluid, it is diluted with warm saline to a volume of 200-500 ml. It is then returned through the distal end of the ileal stoma in a retrograde manner, once every other day.	Combination product: intestinal fluid infusion; Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma.
Active Comparator: Water infusion; Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study. Prepare 200-500 ml of potable water, and then infuse it antegradely from the distal end of the ileal stoma, once every other day.	Combination product: potable water; Infuse potable water through the distal end of the stoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS score(m1)	Improvement in LARS score 1 month after ileostomy reversal surgery between the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).	1 month after ileostomy reversal surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major LARS rate(m1)	Major LARS rate 1 month after ileostomy reversal	1 month after ileostomy reversal
LARS score (m0-12)	Trajectory of change of LARS score after ileostomy reversal surgery in the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).	2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
MSKCC BFI	Memorial Sloan Kettering Cancer Centre Bowel Function Instrument	2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
Wexner score	The Wexner scoring system is a clinical tool used to assess the severity of constipation. Mainly used to quantify the constipation symptoms of patients and their impact on their quality of life. Including five aspects: defecation frequency, difficulty in defecation, emptying sensation, abdominal pain, and time spent in the toilet. The total score range is 0-25 points. A score below 7 points is considered mild constipation, 7-15 points is moderate constipation, and above 15 points is severe constipation.	2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
quality of life for rectal cancer patients	quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )	2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

Collaborators and Investigators

• Sponsor: Pei-Rong Ding

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2028

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: low anterior resection syndrome; antegrade intestinal fluid reinfusion
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Low Anterior Resection Syndrome; Rectal Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Inorganic Chemicals; Beverages; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Oxides; Oxygen Compounds; Water; Drinking Water
• Other Study ID Numbers: 2025-FXY-438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No