Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

Konstantinos Tsimogiannis

Status: Suspended

Conditions: Transsphincteric Anal Fistula; Fistula in Ano

Treatments: Procedure: Autologous fat cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04660903

Fettcell studie

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention

Experimental group

Description:

One arm study - the intervention arm is the only actual

Treatment:

Procedure: Autologous fat cell transplantation