Clinical trial NCT04795180: Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)
Official title: Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients: Short-term Outcomes and Microbiota (BUTYCLO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Ileostomy closure
Butyrate enemas
Microbiota
Rectal Cancer
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Postoperative complication rate
timeFrame: Within 90 days after surgery
measure: Length of hospital stay (number of days)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Diversion colitis evaluation trough rectoscopy in colonic mucosa
timeFrame: At 5-weeks before surgery, At day before surgery
measure: Identification of microbiota modifications in colonic mucosa after irrigations
timeFrame: At 5-weeks before surgery, At day before surgery
measure: Quality of life assessed with Short-Form 36 (SF-36) questionnaire
timeFrame: At hospital discharge and at 1 and 3 months after surgery
measure: Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire
timeFrame: At hospital discharge and at 1 and 3 months after surgery
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta de Girona
Study officials:
References: