NCT03297138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

September 25, 2017

Last Update Submit

May 25, 2018

Conditions

Fistula;Rectal

Outcome Measures

Primary Outcomes (1)

  • surgery success rate

    6 months

Interventions

FiLAC laserPROCEDURE

The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient having a surgical indication using FiLAC laser technique

You may not qualify if:

  • Fistula not well drained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 29, 2017

Study Start

September 16, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

FR(1)