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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Up to 75 ml of fatty tissue mixture fluid
Uppsala University Hospital
Uppsala, Sweden
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
Time frame: 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
Time frame: 12 months after index operation
Postoperative complication
Possible complications linked to index operation
Time frame: 3 months after index operation
Postoperative complication
Possible complications linked to index operation
Time frame: 12 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 ).
Time frame: 3 months after index operation
Functional effects
Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis
Time frame: 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 )
Time frame: 12 months after index operation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Functional effects
Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis
Time frame: 12 months after index operation
Injected fat quantity
The quantity of fat cell mixture injected per patient
Time frame: 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 )
Time frame: 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 )
Time frame: 12 months after index operation