NCT04795180

Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)

Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients: Short-term Outcomes and Microbiota (BUTYCLO)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Low Anterior resection with total mesorectal excision and diversion loop ileostomy is a gold standard surgical treatment in rectal cancer. Ileostomy reversal performed in a second stage carries a high burden of postoperative complications. Terminal ileum and colon dysfunction during bowel disconnection could negatively influence postoperative morbimortality after loop ileostomy reversal in Rectal Cancer patients. Colonic microflora performs anaerobic breakdown of dietary fibre that reaches the gut in regular patients without ileostomy. One of the short-chain fatty acids (SCFAs) produced by bacteria is butyrate, the preferred substrate to be oxidized by colonocytes. The effects of butyrate irrigations before ileostomy closure on colonic mucosa will be studied in 45 rectal cancer patients. The effects of butyrate irrigation trough the efferent limb of loop ileostomy before its closure will be compared to the saline and non-irrigations group. Short term outcomes, colonic microbiota composition and functional outcomes will be evaluated after ileostomy reversal.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Irrigations trough the efferent limb of loop ileostomy	Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure

Timeline

• Start date: 2013-12-10
• Primary completion: 2016-05-17
• Completion: 2016-06-21
• First posted: 2021-03-12
• Last updated: 2021-03-12

Locations

1 site across 1 country: Spain