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

NCT ID: NCT04795180

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-10
• Study Completion Date: 2016-06-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Non-irrigations

No irrigations trough the efferent limb of loop ileostomy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Butyrate irrigations

Butyrate irrigations trough the efferent limb of loop ileostomy

Group Type: EXPERIMENTAL

Irrigations trough the efferent limb of loop ileostomy

Intervention Type: DRUG

Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure

Saline irrigations

Saline irrigations trough the efferent limb of loop ileostomy

Group Type: SHAM_COMPARATOR

Irrigations trough the efferent limb of loop ileostomy

Intervention Type: DRUG

Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure

Interventions

Irrigations trough the efferent limb of loop ileostomy

Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role: lead

Responsible Party

Núria Gómez, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitari Dr. Josep Trueta de Girona

Girona, , Spain

Countries

Spain

Other Identifiers

2011043

Identifier Type: -

Identifier Source: org_study_id