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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Irrigations trough the efferent limb of loop ileostomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ileostomy closure, Butyrate enemas, Microbiota, Rectal Cancer