Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

Study Overview
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Brief Summary
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This is a prospective interventional study on the treatment of transsphincteric fistula in ano. After abdominal or thigh liposuction, fat was injected around the fistula tract that was then transected percutaneously with a sharp cannula and fat injected between and around the cut parts. The internal opening was closed with a suture. Minimum follow up of 12 months is planed

Detailed Description
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The study is intended to be carried out at the Department of Surgery of Uppsala University Hospital, as a single-center study. All (consecutive) otherwise healthy patients between the ages of 18-70 who have been diagnosed with perianal fistula where attempts to close the fistula is considered appropriate are asked to participate. This is done by the examining physician at their visit at the outpatient clinic. These are either patients who already have a relieving seton or those who need to be revised and treated with a seton before final closure. They receive written information about the study plan and have time to think about it. If they choose to participate in the study, they are planed for a visit to one of the surgeons involved in the study and here get another opportunity to ask questions and then also sign an informed consent. This step can be adjusted as telephone contact due to the Covid-19 pandemic. Thereafter, they are included in the study. The participants are operated on only by the surgeons involved, all of whom have undergone practical training in how fat cell transplantation is carried out according to the standardized Coleman method. The procedure itself then takes place as a day surgery operation at the Samariter Hemmet ( part of the Surgical Department, Uppsala University Hospital ) operating department and either as a one- or two-step procedure, depending on whether they have a relieving seton or not. The seton has to be placed sometime before the definitive fatty tissue procedure so that there is no sign of inflammation/infection. A 3- and 12-months follow up visit is then arranged. In these visits, the patients are examined for evaluation of the result, possible residual fistulas, and complications. Wexner score and VAS scale are filed in and saved in their patient files.

Official Title
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Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

Conditions
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Fistula in Ano, Transsphincteric Anal Fistula

Intervention / Treatment
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* Procedure: Autologous fat cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Verified perianal or rectovaginal fistula Healthy individuals that can be accepted for an elective operation with total anesthesia. Signed consent Exclusion Criteria: Patients under the age of 18 or over the age of 75 years Another disease that can affect the perianal are or the procedure Patients that are not able to understand and sign the consent themselves.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>One arm study - the intervention arm is the only actual | Procedure: Autologous fat cell transplantation<br>* Up to 75 ml of fatty tissue mixture fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical healing of fistula in ano | No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic | 3 months after index operation | 
| Clinical healing of fistula in ano | No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic | 12 months after index operation | 
| Postoperative complication | Possible complications linked to index operation | 3 months after index operation | 
| Postoperative complication | Possible complications linked to index operation | 12 months after index operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional effects | Incontinence or constipation after index operation that will be assessed with Wexner score ( On a scale of 0-20, with 0 = perfect continence and 20 = complete incontinence ). | 3 months after index operation | 
| Functional effects | Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis | 3 months after index operation | 
| Functional effects | Incontinence or constipation after index operation that will be assessed with Wexner score ( On a scale of 0-20, with 0 = perfect continence and 20 = complete incontinence ) | 12 months after index operation | 
| Functional effects | Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis | 12 months after index operation | 
| Injected fat quantity | The quantity of fat cell mixture injected per patient | During index operation | 
| Visual Analog Pain Scale score | Pain or discomfort after the treatment, using Visual analog scale, for the first 3 weeks of the postoperative period. The scale ranges from 0 8 no pain ) to 10 ( maximum possible pain ) | 3 months after index operation | 
| Visual Analog Pain Scale score | Pain or discomfort after the treatment, using Visual analog scale, for the first 3 weeks of the postoperative period. The scale ranges from 0 8 no pain ) to 10 ( maximum possible pain ) | 12 months after index operation |