Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-02-28

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

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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.

Conditions

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Fistula in Ano Transsphincteric Anal Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

One arm study - the intervention arm is the only actual

Group Type EXPERIMENTAL

Autologous fat cell transplantation

Intervention Type PROCEDURE

Up to 75 ml of fatty tissue mixture fluid

Interventions

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Autologous fat cell transplantation

Up to 75 ml of fatty tissue mixture fluid

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes