Clinical trial NCT04660903: Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation
Official title: Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Fistula in Ano
Transsphincteric Anal Fistula
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical healing of fistula in ano
timeFrame: 3 months after index operation
measure: Clinical healing of fistula in ano
timeFrame: 12 months after index operation
measure: Postoperative complication
timeFrame: 3 months after index operation
measure: Postoperative complication
timeFrame: 12 months after index operation
Secondary outcomes:
measure: Functional effects
timeFrame: 3 months after index operation
measure: Functional effects
timeFrame: 3 months after index operation
measure: Functional effects
timeFrame: 12 months after index operation
measure: Functional effects
timeFrame: 12 months after index operation
measure: Injected fat quantity
timeFrame: During index operation
measure: Visual Analog Pain Scale score
timeFrame: 3 months after index operation
measure: Visual Analog Pain Scale score
timeFrame: 12 months after index operation
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Wilhelm Graf, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
citation: 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.