Low Anterior Resection SyndromePhase 2/3NCT07537998
Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
A Phase 2/3 study testing intestinal fluid infusion and potable water in people with Low Anterior Resection Syndrome and Rectal Cancer, run by Pei-Rong Ding at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Anterior Resection Syndrome, Rectal Cancer
- What is being tested?
- intestinal fluid infusion and potable water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 10 Apr 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Peirong Ding, M.D, 86-020-87343920, dingpr@sysucc.org.cn
About this study
Official 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.
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
- Being tested
- intestinal fluid infusion, potable water
- Keywords
- low anterior resection syndrome, antegrade intestinal fluid reinfusion
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal fluid infusionCombination product
Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma.
potable waterCombination product
Infuse potable water through the distal end of the stoma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: potable water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month after ileostomy reversal surgery
Secondary outcomes (5)
Major LARS rate(m1)
Major LARS rate 1 month after ileostomy reversal
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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 )
Measured: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pei-Rong Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pei-Rong Ding, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537998
- Sponsor's protocol ID
- 2025-FXY-438
- Status last verified
- Nov 2025
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07537998
- Acronym / sponsor ID
- 2025-FXY-438
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Keywords
- low anterior resection syndrome, antegrade intestinal fluid reinfusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Pei-Rong DingUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intestinal fluid reinfusion | Experimental | Combination Product: intestinal fluid infusionStarting 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. |
| Water infusion | Active comparator | Combination Product: potable waterStarting 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intestinal fluid infusionPrepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma. | Combination product | Intestinal fluid reinfusion |
| potable waterInfuse potable water through the distal end of the stoma. | Combination product | Water infusion |
Primary outcome
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).
5 secondary outcomes
Major LARS rate(m1)
Time frame: 1 month after ileostomy reversal
LARS score (m0-12)
Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
MSKCC BFI
Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
Wexner score
Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intestinal fluid infusion and potable water in people with Low Anterior Resection Syndrome and Rectal Cancer, run by Pei-Rong Ding at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peirong Ding, M.D (86-020-87343920, dingpr@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARS score(m1) (time frame: 1 month after ileostomy reversal surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.