Antegrade intestinal fluid reinfusion to prevent low anterior resection syndrome in rectal cancer patients with ileostomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized controlled Phase 2/3 trial will compare antegrade intestinal fluid reinfusion with antegrade potable water infusion beginning one month after low anterior resection with a diverting ileostomy and continuing until ileostomy reversal. Eligible patients have mid-to-low rectal cancer, a healed anastomosis, good sphincter function, and can care for themselves. Participants will be randomly assigned to one of the two infusion approaches and will keep a symptom diary to document bowel function until and after stoma closure. The main goal is to determine whether reinfusing intestinal fluid reduces the incidence or severity of low anterior resection syndrome compared with water infusion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Peirong Ding, M.D
• Email: dingpr@sysucc.org.cn
• Phone: 86-020-87343920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.