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Cola

No irrigations trough the efferent limb of loop ileostomy

Butyrate irrigations trough the efferent limb of loop ileostomy

Saline irrigations trough the efferent limb of loop ileostomy

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

Irrigations trough the efferent limb of loop ileostomy

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.

1 treatment arm open label

1 treatment arm double-blind

1 treatment arm double-blind

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

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

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.

Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.

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

Sequences of the variable portions of the 16s ribosomal RNA gene

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

Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores. Score from 0-27

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)	NCT04795180	Rectal Cancer	Irrigations tro...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)	NCT04795180	Rectal Cancer	Irrigations tro...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Spots Global Cancer Trial Database for butyrate enemas