Perianal Fistula Treatment With Autologous Adipose Tissue Injection

May 10, 2019 updated by: Gabriele Naldini, Azienda Ospedaliero, Universitaria Pisana

Treatment of Perianal Fistulas Through Injection of Autologous and Micro-fragmented Adipose Tissue: a Prospective Multicentre Study

The study aims to evaluate the efficacy of the local injection of autologous micro-fragmented adipose tissue obtained with the Lipogems®system in patients with trans-sphincteric fistulas untreatable with fistulotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

STUDY BACKGROUND

Perianal fistulas are diseases that, by their nature, do not tend to heal spontaneously and are very rarely cured with medical treatment. Their healing is usually pursued through surgery, which often needs to be repeated due to the natural tendency of the fistulas to recur. A surgical treatment that is currently able to provide a high chance of healing is fistulotomy which, however, can injure the anal sphincter and may result in degrading scars and possible fecal incontinence. One possible strategy could be the lipofilling, i.e., autologous adipose tissue transplant containing, among the many, pericytes and progenitor cells, including adult mesenchymal stem cells.

STUDY DESIGN

This is a no profit interventional prospective multicenter study without drugs where 100 patients (10 each participant centre) with a diagnosis of trans-sphincteric anal fistula that is not suitable to be laid open will be enrolled.

After the enrolment, medical history and clinical data will be collected and pre-operatory exams will be performed.

METHODS

- Harvesting of the adipose tissue

The lower/lateral abdomen or, eventually, the inner/outer thigh will be chosen as donor site for adipose tissue harvesting under general or spinal anaesthesia. Before the harvesting, the donor site will be injected with 100 cc of Klein Solution (500 cc saline, 1 cc epinephrine 1/1000 IU, and 40 cc lidocaine 2%) using a disposable 17 gauge blunt cannula connected to a 60-cc luer-lock syringe. The fat will be then harvested (50-100 cc) using a 13 gauge blunt cannula connected to a 20-ml VacLok® syringe.

- Processing of the adipose tissue with the Lipogems® device

The harvested fat will be immediately processed in the Lipogems® processing kit (Lipogems International Spa, Milan, Italy). Lipogems® is a disposable device that mechanically reduces the size of the adipose tissue clusters while eliminating oily substances and blood residues with pro-inflammatory properties. The entire process is carried out in one surgical step in complete immersion in physiological solution minimizing any traumatic action on the cells and microarchitecture. The processed micro-fragmented fat will be collected in a 60-cc syringe and positioned to decant the excess of saline solution. At the end, the product will be transferred in several 5-cc syringes to be re-injected in the patient.

- Surgical procedure and micro-fragmented adipose tissue (Lipogems®) injection

The micro-fragmented autologous adipose tissue will be injected with wheals of no more than 1cc in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice.

- Follow-up visits and outcome measures

All patients will be assessed at 7 days, 1, 3, 6 and 12 months after the procedure.

Study Type

Observational

Enrollment (Anticipated)

100

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 Contact Backup

Study Locations

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 to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a diagnosis of transphincteric anal fistula that is not suitable to be laid open.

Description

Inclusion Criteria:

  • Patients of both sexes, aged over 18 and under 80 years old.
  • Diagnosis, confirmed by standard methods (magnetic resonance and/or trans anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open) without any secondary tracts and no active septic processes, performed 2-4 weeks after the first perianal access drainage procedure and fistulectomy, with positioning of a drainage seton.
  • Seton placed at least 4-6 weeks previously
  • No previous sphincter saving procedures for the anal fistula
  • No limitations to a periodic follow-up lasting for a total of 12 months
  • Informed consent form signed

Exclusion Criteria:

  • Patients with multiple fistulas
  • Active septic process
  • Patients unable to follow the pathway required by the protocol
  • Patients with active Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infections
  • Patients with Irritable Bowel Syndrome
  • Patients with rectal-vaginal fistulas
  • Patients with a history of cancer lasting less than 5 years
  • Patients undergoing cortisone and/or immunosuppressive and/or anticoagulant therapy
  • Patients with a history rectal or pelvic radiotherapy
  • Pregnant women
  • Patients with connective tissue diseases and/or coagulation diseases and/or uncompensated diabetes mellitus
  • 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lipogems
Lipogems injection in the internal orifice, mucosal, submucosal and muscular layer, in the fistula tract and external orifice.
Procedure: Lipogems
Autologous micro-fragmented adipose tissue is injected in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice in addition to anal flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: 12 months
Closing of the fistula tract (internal and external orifice)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety collecting all types of adverse events
Time Frame: 12 months
All types of adverse events intra-, peri-, or post-operative will be collected
12 months
Pain assessed using the Visual Analogue Scale (VAS) for pain
Time Frame: 12 months
Pain will be assessed using the Visual Analogue Scale for pain (VAS 0-10), where 0 is no pain and 10 is the maximum pain.
12 months
Continence
Time Frame: 12 months

Continence will be assessed with the Wexner Continence Grading Scale. The score takes into account the type and frequency of incontinence and the extent to which it alters the patient's life.

This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
12 months
Patient's satisfaction
Time Frame: 12 months
Patient's satisfaction will be evaluated using a visual analogue scale 0-5, where 0 is no satisfaction and 5 is maximum satisfaction.
12 months
Non inferiority compared with the Advancement flap technique
Time Frame: 12 months
Non-inferiority will be determined comparing healing rate of Lipogems with retrospective data on the advancement flap.
12 months

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliero, Universitaria Pisana

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)

February 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOUPisana_1

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

product manufactured in and exported from the U.S.

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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