Fistula Laser Closure
Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT03297138
Collaborator
(none)
60
1
15.5
3.9
Study Details
Study Description
Brief Summary
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.
For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.
Recently there is one of them , named FiLAC using a clip system not yet evaluated.
The purpose is to assess the success rate of his new surgery technique.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Fistula Laser Closure
Actual Study Start Date
:
Sep 16, 2016
Actual Primary Completion Date
:
Dec 31, 2016
Actual Study Completion Date
:
Dec 31, 2017
Outcome Measures
Primary Outcome Measures
- surgery success rate [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patient with anal fistula drained at least 3 months before inclusion.
Exclusion Criteria:
- Fistula not well drained
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France | France | 75014 |
Sponsors and Collaborators
- Groupe Hospitalier Paris Saint Joseph
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT03297138
Other Study ID Numbers:
- FILAC
First Posted:
Sep 29, 2017
Last Update Posted:
May 30, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: