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

February 27, 2024 updated by: Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08006
        • Recruiting
        • Hospital Clínic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing rate
Time Frame: 1 year
Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year
Treatment related adverse events
Time Frame: 1 year
Reported adverse events designated as related to treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fistula_CM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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