Rectal Cancer
Conditions
Keywords
Ileostomy closure, Butyrate enemas, Microbiota, Rectal Cancer
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.
Interventions
DRUGIrrigations trough the efferent limb of loop ileostomy
Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure
Sponsors
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
1 treatment arm open label 1 treatment arm double-blind 1 treatment arm double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication rate | Within 90 days after surgery | 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. |
| Length of hospital stay (number of days) | Up to 4 weeks | Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diversion colitis evaluation trough rectoscopy in colonic mucosa | At 5-weeks before surgery, At day before surgery | 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 |
| Identification of microbiota modifications in colonic mucosa after irrigations | At 5-weeks before surgery, At day before surgery | Sequences of the variable portions of the 16s ribosomal RNA gene |
| Quality of life assessed with Short-Form 36 (SF-36) questionnaire | At hospital discharge and at 1 and 3 months after surgery | 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 |
| Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire | At hospital discharge and at 1 and 3 months after surgery | Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores. Score from 0-27 |
Countries
Spain
Outcome results
None listed