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

NCT07537998 | Recruiting Phase 2

• 1 other identifier: 2025-FXY-438
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does it work to prevent LARS by antegrade intestinal fluid reinfusion before performing the ileostomy reversal surgery?
2. 2.Is antegrade intestinal fluid reinfusion more effective than water infusion in preventing LARS.
3. 3.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.
4. 4.Keep a diary of their symptoms.

Conditions

Low Anterior Resection Syndrome; Rectal Cancer

Keywords

low anterior resection syndrome; antegrade intestinal fluid reinfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Major LARS rate(m1)

  1 month after ileostomy reversal

• LARS score (m0-12)

  2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

• MSKCC BFI

  2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

• Wexner score

  2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

• quality of life for rectal cancer patients

  2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

Study Arms (2)

Intestinal fluid reinfusion

EXPERIMENTAL

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

Water infusion

ACTIVE COMPARATOR

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

Interventions

intestinal fluid infusion COMBINATION_PRODUCT

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

Intestinal fluid reinfusion

potable water COMBINATION_PRODUCT

Infuse potable water through the distal end of the stoma.

Water infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pei-Rong Ding: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Interventions

Drinking Water

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Peirong Ding, M.D

CONTACT

86-020-87343920; dingpr@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2028
• Last Updated: April 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)