Recruiting nowPhase 3Randomised
| Registry number | NCT07537998 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 160 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Pei-Rong Ding |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Combination product intestinal fluid infusion
- Combination product potable water
What it is measuring
LARS score(m1)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07537998, registered by Pei-Rong Ding on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.