Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

Fistula in Ano Clinical Trial

Official title:

Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04660903
• Other study ID #: Fettcell studie
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: June 2022
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: February 28, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano
• Rectal Fistula
• Transsphincteric Anal Fistula

Intervention

Procedure:
• Autologous fat cell transplantation
Up to 75 ml of fatty tissue mixture fluid

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Konstantinos Tsimogiannis

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Borowski DW, Gill TS, Agarwal AK, Tabaqchali MA, Garg DK, Bhaskar P. Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique. Surg Innov. 2015 Dec;22(6):593-600. doi: 10.1177/1553350615572656. Epub 2015 Feb 20. — View Citation

Choi S, Ryoo SB, Park KJ, Kim DS, Song KH, Kim KH, Chung SS, Shin EJ, Cho YB, Oh ST, Kang WK, Kim MH. Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn's disease: a phase II clinical trial for safety and efficacy. Tech Coloproctol. 2017 May;21(5):345-353. doi: 10.1007/s10151-017-1630-z. Epub 2017 May 31. — View Citation

Dozois EJ, Lightner AL, Mathis KL, Chua HK, Kelley SR, Fletcher JG, Dietz AB, Friton JJ, Butler GW, Faubion WA. Early Results of a Phase I Trial Using an Adipose-Derived Mesenchymal Stem Cell-Coated Fistula Plug for the Treatment of Transsphincteric Cryptoglandular Fistulas. Dis Colon Rectum. 2019 May;62(5):615-622. doi: 10.1097/DCR.0000000000001333. — View Citation

Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a. — View Citation

Norderval S, Lundby L, Hougaard H, Buntzen S, Weum S, de Weerd L. Efficacy of autologous fat graft injection in the treatment of anovaginal fistulas. Tech Coloproctol. 2018 Jan;22(1):45-51. doi: 10.1007/s10151-017-1739-0. Epub 2017 Dec 28. — View Citation

Pu LLQ, Coleman SR, Cui X, Ferguson REH Jr, Vasconez HC. Autologous fat grafts harvested and refined by the Coleman technique: a comparative study. Plast Reconstr Surg. 2008 Sep;122(3):932-937. doi: 10.1097/PRS.0b013e3181811ff0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after index operation
Primary	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	12 months after index operation
Primary	Postoperative complication	Possible complications linked to index operation	3 months after index operation
Primary	Postoperative complication	Possible complications linked to index operation	12 months after index operation
Secondary	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 ).	3 months after index operation
Secondary	Functional effects	Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis	3 months after index operation
Secondary	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 )	12 months after index operation
Secondary	Functional effects	Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis	12 months after index operation
Secondary	Injected fat quantity	The quantity of fat cell mixture injected per patient	During index operation
Secondary	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 )	3 months after index operation
Secondary	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 )	12 months after index operation