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

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.

This trial will test whether putting a patient's intestinal fluid back through their ileostomy before it is closed can prevent low anterior resection syndrome in people treated for mid to low rectal cancer.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07537998 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with mid-to-low rectal cancer who underwent radical low anterior resection with a prophylactic ileostomy, have a well-healed anastomosis at one month, good anal sphincter function, and can manage stoma care.

Not a fit: Patients with anastomotic leakage, poor overall health or self-care ability, preexisting inflammatory bowel disease, inability to reduce the stoma, or poor adherence are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the technique could reduce bowel dysfunction after ileostomy reversal and improve quality of life for people who have had low anterior resection.

How similar studies have performed: This antegrade intestinal fluid reinfusion approach is relatively novel with limited prior clinical evidence and few large randomized trials directly comparing it to water infusion.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Peirong Ding, M.D

Conditions: Low Anterior Resection Syndrome, Rectal Cancer, low anterior resection syndrome, antegrade intestinal fluid reinfusion