Enterocutaneous FistulasNCT01990833
Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application
An observational study of Enterocutaneous Fistulas, run by Jianan Ren.
Trial summary
For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Enterocutaneous Fistulas
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2013
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Low-output enterocutaneous fistulas receiving glue application
Who may be able to join
- above 18 years old;
- single tubular (tract length >2 cm) ECF;
- low output volume (<200 ml/24h);
Who cannot join
- fistulas of cancer-infiltrated;
- associated abscess;
- foreign bodies;
- distal bowel obstruction;
About this study
For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.
- Conditions
- Enterocutaneous Fistulas
- Medical subject headings
- Intestinal Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula closure after glue application
No fistula output
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterocutaneous FistulasStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianan Ren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianan Ren, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990833
- Sponsor's protocol ID
- 20120101
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application
- ClinicalTrials.gov ID
- NCT01990833
- Acronym / sponsor ID
- 20120101
- Conditions
- Enterocutaneous Fistulas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jianan RenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Nov 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.
For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low-output enterocutaneous fistulas receiving glue application
Key inclusion criteria (3 listed)
- above 18 years old;
- single tubular (tract length >2 cm) ECF;
- low output volume (<200 ml/24h);
Key exclusion criteria (4 listed)
- fistulas of cancer-infiltrated;
- associated abscess;
- foreign bodies;
- distal bowel obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fistula closure after glue application
Time frame: 7 days
No fistula output
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 25 Nov 2013.
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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?
An observational study of Enterocutaneous Fistulas, run by Jianan Ren.
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 3 inclusion and 4 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 25 Nov 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.
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?
Fistula closure after glue application (time frame: 7 days). 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 25 Nov 2013.