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

Rectal Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795180
• Other study ID #: 2011043
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2013
• Est. completion date: June 21, 2016

Study information

• Verified date: March 2021
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 21, 2016
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr. Josep Trueta de Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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