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

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Drug: Irrigations trough the efferent limb of loop ileostomy

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain, 17001
    • Hospital Universitari Dr. Josep Trueta de Girona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-irrigations; No irrigations trough the efferent limb of loop ileostomy
Experimental: Butyrate irrigations; Butyrate irrigations trough the efferent limb of loop ileostomy	Drug: Irrigations trough the efferent limb of loop ileostomy; Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure
Sham Comparator: Saline irrigations; Saline irrigations trough the efferent limb of loop ileostomy	Drug: Irrigations trough the efferent limb of loop ileostomy; Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complication rate	Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as: Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.	Within 90 days after surgery
Length of hospital stay (number of days)	Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diversion colitis evaluation trough rectoscopy in colonic mucosa	Diversion colitis was graded as follows: Grade 0: Normal mucosa, Grade 1: Erythematous mucosa, Grade 2: Erythema and mucosa edema and Grade 3: Spontaneous bleeding or bleeding with the slightest contact with rectoscopy	At 5-weeks before surgery, At day before surgery
Identification of microbiota modifications in colonic mucosa after irrigations	Sequences of the variable portions of the 16s ribosomal RNA gene	At 5-weeks before surgery, At day before surgery
Quality of life assessed with Short-Form 36 (SF-36) questionnaire	This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health. Score from 0-100	At hospital discharge and at 1 and 3 months after surgery
Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire	Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores. Score from 0-27	At hospital discharge and at 1 and 3 months after surgery

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2013
• Primary Completion (Actual): May 17, 2016
• Study Completion (Actual): June 21, 2016

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Microbiota; Rectal Cancer; Ileostomy closure; Butyrate enemas
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2011043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No