Rectal stimulation with prebiotics and probiotics before ileostomy reversal: a study protocol for a randomized...

Area of Science:

• Colorectal Surgery
• Gastroenterology
• Clinical Trials

Background:

• Ileostomy closure frequently leads to postoperative complications, with adynamic ileus being the most common (up to 32%).
• Adynamic ileus causes delayed oral intake, abdominal distention, prolonged hospitalization, and increased patient discomfort.
• This study addresses the need for effective strategies to mitigate ileostomy reversal complications.

Purpose of the Study:

• To evaluate the efficacy of rectal administration of prebiotics and probiotics as a stimulus before ileostomy reversal.
• To determine if this intervention can reduce the incidence of adynamic ileus and accelerate intestinal transit.
• To improve patient outcomes and reduce the burden of ileostomy closure.

Main Methods:

• Open-label, randomized controlled clinical trial protocol.
• Adult patients with rectal cancer undergoing loop ileostomy for protection will be included.
• Intervention group receives daily rectal saline with prebiotics/probiotics for 15 days pre-closure; control group receives no stimulation.

Main Results:

• Patient enrollment began January 2023, with study completion anticipated by July 2025.
• Primary outcomes include incidence of adynamic ileus and time to intestinal transit (first flatus/evacuation).
• Data collection and analysis are ongoing.

Conclusions:

• Findings may offer novel insights into managing patients undergoing ileostomy reversal.
• This intervention could potentially optimize postoperative recovery and reduce morbidity.
• Results will inform clinical practice guidelines for ileostomy closure management.