Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

June 8, 2022 updated by: Konstantinos Tsimogiannis
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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical healing of fistula in ano
Time Frame: 3 months after index operation
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
Time Frame: 12 months after index operation
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
Time Frame: 3 months after index operation
Possible complications linked to index operation
3 months after index operation
Postoperative complication
Time Frame: 12 months after index operation
Possible complications linked to index operation
12 months after index operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional effects
Time Frame: 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 ).
3 months after index operation
Functional effects
Time Frame: 3 months after index operation
Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis
3 months after index operation
Functional effects
Time Frame: 12 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 )
12 months after index operation
Functional effects
Time Frame: 12 months after index operation
Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis
12 months after index operation
Injected fat quantity
Time Frame: During index operation
The quantity of fat cell mixture injected per patient
During index operation
Visual Analog Pain Scale score
Time Frame: 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 )
3 months after index operation
Visual Analog Pain Scale score
Time Frame: 12 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 )
12 months after index operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konstantinos Tsimogiannis

Investigators

  • Study Director: Wilhelm Graf, Professor, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fettcell studie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not allowed by the ethical committee and data legislations. If this is required, completion of the Ethical decision is needed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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