Ileostomy - StomaPhase 2NCT03424447
Stimulation of the Efferent Loop Before Loop Ileostomy Closure
A Phase 2 study testing efferent limb stimulation in people with Ileostomy - Stoma and Ileostomy; Complications, run by Hospital de Basurto at 1 site in Spain.
Trial summary
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ileostomy - Stoma, Ileostomy; Complications, Stoma Ileostomy
- What is being tested?
- efferent limb stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2014to 30 Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with loop ileostomy
- Barium transit throught the efferent limb without leaks
Who cannot join
- Chemotherapy at the moment
- Ileostomy closure at the same admission than the ileostomy creation
Trial locations and contacts
1 site in 1 country.
Alba Vázquez-Melero contact
Alberto Loizate contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de Basurto
Bilbao, Vizcaya, 48002
Alba Vázquez-Melero, albav6@hotmail.com
Alba Vázquez-Melero
About this study
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay
Read the detailed description
Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.
- Being tested
- efferent limb stimulation
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efferent limb stimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Non stimulated | No intervention | Prospective data obtained from non stimulated patients |
| Stimulated | Experimental | Prospective data obtaied from stimulated patients Receives: Procedure: efferent limb stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative ileus
Need for a nasogastric tube
Measured: during the admission for the ileostomy closure
bowel movement
day of hospital stay whe stool or flatus begins
Measured: during the admission for the ileostomy closure
Secondary outcomes (1)
hospital stay
days
Measured: during the admission for the ileostomy closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start20 Nov 2014
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Ambispective cohort study
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Basurto
- Sponsor type
- University, hospital or other
- Collaborators
- Alberto Loizate Totoricaguena, Pedro García Alonso
- Responsible party
- Principal investigator, ALBA VÁZQUEZ-MELERO, Hospital de Basurto
- Investigators
- Alba Vázquez-Melero, Principal investigator, general surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424447
- Sponsor's protocol ID
- Hospital de Basurto
- Status last verified
- Jan 2018
- First submitted
- 31 Jan 2018
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of the Efferent Loop Before Loop Ileostomy Closure
- ClinicalTrials.gov ID
- NCT03424447
- Acronym / sponsor ID
- Hospital de Basurto
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospital de BasurtoUniversity, hospital or other
- Collaborators
- Alberto Loizate Totoricaguena, Pedro García Alonso
- Study start
- 20 Nov 2014
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 7 Feb 2018 (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.
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay
Detailed description
Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ambispective cohort study
| Arm | Type | Receives |
|---|---|---|
| Non stimulated | No intervention | –Prospective data obtained from non stimulated patients |
| Stimulated | Experimental | Procedure: efferent limb stimulationProspective data obtaied from stimulated patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with loop ileostomy
- Barium transit throught the efferent limb without leaks
Key exclusion criteria (2 listed)
- Chemotherapy at the moment
- Ileostomy closure at the same admission than the ileostomy creation
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 |
|---|---|---|
| efferent limb stimulation | Procedure or surgery | Stimulated |
Primary outcome
postoperative ileus
Time frame: during the admission for the ileostomy closure
Need for a nasogastric tube
bowel movement
Time frame: during the admission for the ileostomy closure
day of hospital stay whe stool or flatus begins
1 secondary outcome
hospital stay
Time frame: during the admission for the ileostomy closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Alba Vázquez-Melero contact
Alberto Loizate contact
Alba Vázquez-Melero principal investigator
general surgeon
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 efferent limb stimulation in people with Ileostomy - Stoma and Ileostomy; Complications, run by Hospital de Basurto 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 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alba Vázquez-Melero (albav6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative ileus (time frame: during the admission for the ileostomy closure). 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 7 Feb 2018.