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

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status and phase: Completed; Phase 2

Conditions: Rectal Cancer

Treatments: Drug: Irrigations trough the efferent limb of loop ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04795180

2011043

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Patients waiting for an elective ileostomy reversal after Rectal cancer surgical treatment

Exclusion criteria

• Inflammatory bowel disease
• Abnormal preoperative findings trough rectoscopy or CT-enema scan that precluded a safe ileostomy closure
• Ileal pouch, poor treatment compliance
• Pregnancy or lactation
• Unwillingness to use adequate contraception throughout the study period
• Combined surgeries
• The impossibility to understand the informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Non-irrigations

No Intervention group

Description:

No irrigations trough the efferent limb of loop ileostomy

Butyrate irrigations

Experimental group

Description:

Butyrate irrigations trough the efferent limb of loop ileostomy

Treatment:

Drug: Irrigations trough the efferent limb of loop ileostomy

Saline irrigations

Sham Comparator group

Description:

Saline irrigations trough the efferent limb of loop ileostomy

Treatment:

Drug: Irrigations trough the efferent limb of loop ileostomy