NCT07537998 Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
| NCT ID | NCT07537998 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Pei-Rong Ding |
| Condition | Low Anterior Resection Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2027-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2026-04-10 with a primary completion date of 2027-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07537998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Low Anterior Resection Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07537998 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07537998 currently recruiting?
Yes, NCT07537998 is actively recruiting participants. Contact the research team at dingpr@sysucc.org.cn for enrollment information.
Where is the NCT07537998 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07537998 clinical trial?
NCT07537998 is sponsored by Pei-Rong Ding. The trial plans to enroll 160 participants.