Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irrigations trough the efferent limb of loop ileostomy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Non-irrigations
- description
- No irrigations trough the efferent limb of loop ileostomy
- type
- EXPERIMENTAL
- label
- Butyrate irrigations
- description
- Butyrate irrigations trough the efferent limb of loop ileostomy
- interventionNames
- Drug: Irrigations trough the efferent limb of loop ileostomy
- type
- SHAM_COMPARATOR
- label
- Saline irrigations
- description
- Saline irrigations trough the efferent limb of loop ileostomy
- interventionNames
- Drug: Irrigations trough the efferent limb of loop ileostomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available