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CompletedNCT01990833Updated Nov 25, 2013

Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

An observational study in Enterocutaneous Fistulas, sponsored by Jianan Ren. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Jianan Ren · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
22
Ages
18 Years to 65 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Enterocutaneous Fistulas

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03

In context

Intestinal Fistula

21 studies on the registry are indexed under Intestinal Fistula; 2 are open to participants now.

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Lead sponsor

This is the only study on the registry with Jianan Ren as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Low-output enterocutaneous fistulas receiving glue application

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • above 18 years old;
  • single tubular (tract length >2 cm) ECF;
  • low output volume (\<200 ml/24h);

Exclusion criteria

Exclusion Criteria:

  • fistulas of cancer-infiltrated;
  • associated abscess;
  • foreign bodies;
  • distal bowel obstruction;
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Fistula closure after glue application

    No fistula output

    Time frame: 7 days

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01990833
Lead sponsor
Jianan Ren
Responsible party
Jianan Ren (Vice president, Jinling Hospital, China) — Sponsor-investigator
First posted
Nov 25, 2013
Start date
Jan 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Nov 25, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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