Ileostomy; ComplicationsPhase 3NCT01881594
Stimulation of Efferent Loop Prior to Ileostomy Closure
A Phase 3 study testing Procedure/Surgery in people with Ileostomy; Complications, run by Hospital Universitario Virgen de la Arrixaca.
Trial summary
The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy; Complications
- What is being tested?
- Procedure/Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 3
- 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
- protective ileostomy after rectal cancer surgery
Who cannot join
- under 18 years
About this study
The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.
Read the detailed description
Stimulation was performed ten days prior to the intervention, through the efferent limb of the ileostomy with 500 cc of a thickening substance (saline and nutritional thickener)
- Conditions
- Ileostomy; Complications
- Being tested
- Procedure/Surgery
- Keywords
- ileostomy closure,postoperative ileus,stimulation ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/SurgeryProcedure or surgery
Also called Stimulation
daily stimulation of efferent loop prior to surgery (ileostomy closure)
| Study group | Role | What they receive |
|---|---|---|
| No stimulation | Active comparator | unstimulated patients prior to surgery,ileostomy closure surgery without prior stimulation of efferent limb. Receives: Procedure: Procedure/Surgery |
| Stimulation | Experimental | stimulation of the efferent limb of the ileostomy prior to ileostomy closure. Receives: Procedure: Procedure/Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative ileus
Measured: within the first days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy; ComplicationsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Lujan, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881594
- Sponsor's protocol ID
- SEL-001
- Status last verified
- Jun 2013
- First submitted
- 29 Apr 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.
PubMed 25380005
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Efferent Loop Prior to Ileostomy Closure
- ClinicalTrials.gov ID
- NCT01881594
- Acronym / sponsor ID
- SEL-001
- Conditions
- Ileostomy; Complications
- Keywords
- ileostomy closure,postoperative ileus,stimulation ileostomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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 aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.
Detailed description
Stimulation was performed ten days prior to the intervention, through the efferent limb of the ileostomy with 500 cc of a thickening substance (saline and nutritional thickener)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No stimulation | Active comparator | Procedure: Procedure/Surgeryunstimulated patients prior to surgery,ileostomy closure surgery without prior stimulation of efferent limb. |
| Stimulation | Experimental | Procedure: Procedure/Surgerystimulation of the efferent limb of the ileostomy prior to ileostomy closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- protective ileostomy after rectal cancer surgery
Key exclusion criteria (1 listed)
- under 18 years
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 |
|---|---|---|
| Procedure/SurgeryAlso: Stimulationdaily stimulation of efferent loop prior to surgery (ileostomy closure) | Procedure or surgery | No stimulation, Stimulation |
Primary outcome
postoperative ileus
Time frame: within the first days 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 19 Jun 2013.
- Derived from this study: PubMed 25380005Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procedure/Surgery in people with Ileostomy; Complications, run by Hospital Universitario Virgen de la Arrixaca.
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 1 inclusion and 1 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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 ileus (time frame: within the first days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881594, which also lists 1 linked publication.
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 19 Jun 2013.