Perianal Fistula Treatment With Autologous Adipose Tissue Injection
|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: NCT03913910|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment|
|Perianal Fistula||Procedure: Lipogems|
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.
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.
- 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|
|Estimated Enrollment :||100 participants|
|Official Title:||Treatment of Perianal Fistulas Through Injection of Autologous and Micro-fragmented Adipose Tissue: a Prospective Multicentre Study|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Lipogems injection in the internal orifice, mucosal, submucosal and muscular layer, in the fistula tract and external orifice.
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.
- Healing [ Time Frame: 12 months ]Closing of the fistula tract (internal and external orifice)
- Safety collecting all types of adverse events [ Time Frame: 12 months ]All types of adverse events intra-, peri-, or post-operative will be collected
- 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.
- 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).
- 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.
- 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.
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): NCT03913910
|Contact: Gabriele Naldini, MDfirstname.lastname@example.org|
|Contact: Alessandro Sturiale, MDemail@example.com|
|AOU Pisana - Cisanello||Recruiting|
|Pisa, Toscana, Italy, 56124|
|Contact: Gabriele Naldini, MD firstname.lastname@example.org|
|Contact: Alessandro Sturiale 0039 3311372249 email@example.com|