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NCT Number: NCT04795180

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitari Dr. Josep Trueta de Girona

Girona, 17001, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irrigations trough the efferent limb of loop ileostomy

Drug

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

Primary outcomes

  1. Postoperative complication rate

    Time frame: 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.

  2. Length of hospital stay (number of days)

    Time frame: Up to 4 weeks

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

Secondary outcomes

  1. Diversion colitis evaluation trough rectoscopy in colonic mucosa

    Time frame: 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

  2. Identification of microbiota modifications in colonic mucosa after irrigations

    Time frame: At 5-weeks before surgery, At day before surgery

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

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

    Time frame: 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

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

    Time frame: At hospital discharge and at 1 and 3 months after surgery

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

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

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

Acronym: BUTYCLO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2021
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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