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NCT Number: NCT07537998

Antegrade Intestinal Fluid Reinfusion 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.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Peirong Ding, M.D

CONTACT

[email protected]

86-020-87343920

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intestinal fluid infusion

Combination Product

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

potable water

Combination Product

Infuse potable water through the distal end of the stoma.

Primary outcomes

  1. LARS score(m1)

    Time frame: 1 month after ileostomy reversal surgery

    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).

Secondary outcomes

  1. Major LARS rate(m1)

    Time frame: 1 month after ileostomy reversal

    Major LARS rate 1 month after ileostomy reversal

  2. LARS score (m0-12)

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

    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).

  3. MSKCC BFI

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

    Memorial Sloan Kettering Cancer Centre Bowel Function Instrument

  4. Wexner score

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

    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.

  5. quality of life for rectal cancer patients

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

    quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )

Study contacts

Contact information is provided by the study sponsor or research team.

Peirong Ding, M.D

CONTACT

[email protected]

86-020-87343920

Sponsors and collaborators

Lead sponsor

Pei-Rong Ding

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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