Ileostomy Clinical Trials

Clinical trials related to Ileostomy Procedure

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.

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Peirong Ding, M.D
dingpr@sysucc.org.cn
86-020-87343920
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2028-04-10
Participants
Target number of participants: 160
Treatments
Experimental: Intestinal fluid reinfusion
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.
Active_comparator: Water infusion
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.
Related Therapeutic Areas
Sponsors
Leads: Pei-Rong Ding

This content was sourced from clinicaltrials.gov