Rectal CancerPhase 2BUTYCLONCT04795180
Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)
A Phase 2 study testing Irrigations trough the efferent limb of loop ileostomy in people with Rectal Cancer, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Irrigations trough the efferent limb of loop ileostomy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 10 Dec 2013to 21 Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients waiting for an elective ileostomy reversal after Rectal cancer surgical treatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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
- Rectal Cancer
- Being tested
- Irrigations trough the efferent limb of loop ileostomy
- Keywords
- Ileostomy closure, Butyrate enemas, Microbiota, Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigations trough the efferent limb of loop ileostomyDrug
Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure
| Study group | Role | What they receive |
|---|---|---|
| Non-irrigations | No intervention | No irrigations trough the efferent limb of loop ileostomy |
| Butyrate irrigations | Experimental | Butyrate irrigations trough the efferent limb of loop ileostomy Receives: Drug: Irrigations trough the efferent limb of loop ileostomy |
| Saline irrigations | Sham comparator | Saline irrigations trough the efferent limb of loop ileostomy Receives: Drug: Irrigations trough the efferent limb of loop ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days after surgery
Length of hospital stay (number of days)
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.
Measured: Up to 4 weeks
Secondary outcomes (4)
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
Measured: At 5-weeks before surgery, At day before surgery
Identification of microbiota modifications in colonic mucosa after irrigations
Sequences of the variable portions of the 16s ribosomal RNA gene
Measured: At 5-weeks before surgery, At day before surgery
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
Measured: At hospital discharge and at 1 and 3 months after surgery
Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire
Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores. Score from 0-27
Measured: At hospital discharge and at 1 and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start10 Dec 2013
- Primary completion17 May 2016
- Study completion21 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Núria Gómez, MD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795180
- Sponsor's protocol ID
- 2011043
- Acronym
- BUTYCLO
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04795180
- Acronym / sponsor ID
- BUTYCLO / 2011043
- Conditions
- Rectal Cancer
- Keywords
- Ileostomy closure, Butyrate enemas, Microbiota, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 10 Dec 2013 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 21 Jun 2016 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-irrigations | No intervention | –No irrigations trough the efferent limb of loop ileostomy |
| Butyrate irrigations | Experimental | Drug: Irrigations trough the efferent limb of loop ileostomyButyrate irrigations trough the efferent limb of loop ileostomy |
| Saline irrigations | Sham comparator | Drug: Irrigations trough the efferent limb of loop ileostomySaline irrigations trough the efferent limb of loop ileostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Patients waiting for an elective ileostomy reversal after Rectal cancer surgical treatment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigations trough the efferent limb of loop ileostomyIrrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure | Drug | Butyrate irrigations, Saline irrigations |
Primary outcome
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.
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.
4 secondary outcomes
Diversion colitis evaluation trough rectoscopy in colonic mucosa
Time frame: At 5-weeks before surgery, At day before surgery
Identification of microbiota modifications in colonic mucosa after irrigations
Time frame: At 5-weeks before surgery, At day before surgery
Quality of life assessed with Short-Form 36 (SF-36) questionnaire
Time frame: At hospital discharge and at 1 and 3 months after surgery
Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire
Time frame: At hospital discharge and at 1 and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irrigations trough the efferent limb of loop ileostomy in people with Rectal Cancer, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rate (time frame: Within 90 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.