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

NCT04795180 | Completed Phase 2

• 1 other identifier: 2011043
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Ileostomy closure; Butyrate enemas; Microbiota; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Diversion colitis evaluation trough rectoscopy in colonic mucosa

  At 5-weeks before surgery, At day before surgery

• Identification of microbiota modifications in colonic mucosa after irrigations

  At 5-weeks before surgery, At day before surgery

• Quality of life assessed with Short-Form 36 (SF-36) questionnaire

  At hospital discharge and at 1 and 3 months after surgery

• Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire

  At hospital discharge and at 1 and 3 months after surgery

Study Arms (3)

Non-irrigations

NO INTERVENTION

No irrigations trough the efferent limb of loop ileostomy

Butyrate irrigations

EXPERIMENTAL

Butyrate irrigations trough the efferent limb of loop ileostomy

Drug: Irrigations trough the efferent limb of loop ileostomy

Saline irrigations

SHAM COMPARATOR

Saline irrigations trough the efferent limb of loop ileostomy

Drug: Irrigations trough the efferent limb of loop ileostomy

Interventions

Irrigations trough the efferent limb of loop ileostomy DRUG

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

Butyrate irrigations; Saline irrigations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, 17001, Spain

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 1 treatment arm open label 1 treatment arm double-blind 1 treatment arm double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 12, 2021
• Study Start: December 10, 2013
• Primary Completion: May 17, 2016
• Study Completion: June 21, 2016
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

ES (1)