The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection (Fistula_CM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04750499
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Hospital Clinic of Barcelona

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.

Condition or disease Intervention/treatment Phase
Anal Fistula Procedure: Adipose tissue injection associated with endorectal advancement flap. Not Applicable

Detailed Description:

Treatment of anal fistula pursues permanent healing and preservation of anal continence, not always easy goals in complex anal fistulas.

In patients with Crohn's disease, simple surgery (ligation of the path and suturing of the internal orifice) associated with injections of stem cells derived from autologous or allogeneic adipose tissue has been shown to cure up to 70%. of the cases. Similar results have been obtained in small series of patients with fistulas of cryptoglandular origin and also in rectourethral and rectovaginal fistulas of other etiologies. Unfortunately, this treatment is time consuming and extremely expensive.

Fresh adipose tissue is an alternative source of mesenchymal stem cells (MSC) with regenerative capabilities, immunomodulatory angiogenic and anti-inflammatory effects. The injection of fresh adipose tissue, obtained by liposuction from the same patient, is currently a therapeutic alternative used in regenerative medicine, plastic and orthopedic surgery indications, as well in other fields. Beneficial effects of fresh adipose tissue on anus fistulas and fecal incontinence have also been reported.

The aim of the present study is to evaluate the effectiveness of the injection of autologous, microfragmented and minimally manipulated adipose tissue, associated with a surgical technique that obtains by itself up to 70% cure in order to add the benefits of surgery with those in regenerative medicine hoping that the beneficial effects of MSC will aid in the healing and repair process.

A prospective study is proposed in 12 patients with non-Crohn's-related complex anals fistulas. Whenever possible, the endorectal advancement flap technique will be applied; in blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Complex Perianal Fistulas, in Patients Without Crohn's Disease, by Endorectal Advancement Flap Associated With Injection of Autologous and Micro-fragmented Adipose Tissue
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment
Patients with complex anal fistulas, non related to Crohn's disease.
 Procedure: Adipose tissue injection associated with endorectal advancement flap.
Injection of adipose tissue will be associated with endorectal advancement flap technique. In blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Healing rate [ Time Frame: 1 year ]
    Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.


Secondary Outcome Measures :
  1. Incontinence rate [ Time Frame: 1 year ]
    Presence of Fecal Incontinence Measured by the Wexner score instrument, The scoring of the instrument ranges from 0 (no incontinence) to 20 (complete incontinence).

  2. Treatment related adverse events [ Time Frame: 1 year ]
    Reported adverse events designated as related to treatment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both genders, aged over 18 years old.
  • Diagnosis, confirmed by standard methods (magnetic resonance and/or trans-anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open).
  • Seton placed at least 4-6 weeks previously.
  • No limitations to a periodic follow-up lasting for a total of 12 months
  • Informed consent form signed.

Exclusion Criteria:

  • Active septic process.
  • Patients unable to follow the pathway required by the protocol.
  • Pregnant women.
  • Failure to sign the informed consent form
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750499


Contacts
Layout table for location contacts
Contact: Salvador Guillaumes, MD PhD +34 687 795 458 guillaumes@clinic.cat

Locations
Layout table for location information
Spain
Hospital Clínic Recruiting
Barcelona, Spain, 08006
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Layout table for investigator information
Principal Investigator: Salvador Guillaumes, MD PhD Hospital Clinic of Barcelona
Principal Investigator: Nils Jimmy Hidalgo, MD Hospital Clinic of Barcelona
Principal Investigator: Irene Bachero, MD Hospital Clinbic. Barcelona
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04750499    
Other Study ID Numbers: Fistula_CM1
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Clinic of Barcelona:
Complex Anal Fistula
Mesenchymal Stem Cells
Microfragmented adipose tissue
Regenerative Medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases