Fistula in Ano, Transsphincteric Anal Fistula
Conditions
Brief summary
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
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.
Interventions
PROCEDUREAutologous fat cell transplantation
Up to 75 ml of fatty tissue mixture fluid
Sponsors
Konstantinos Tsimogiannis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical healing of fistula in ano | 3 months after index operation | No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic |
| Postoperative complication | 3 months after index operation | Possible complications linked to index operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional effects | 3 months after index operation | 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 ). |
| Injected fat quantity | During index operation | The quantity of fat cell mixture injected per patient |
| Visual Analog Pain Scale score | 3 months after index operation | 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 ) |
Countries
Sweden
Outcome results
None listed