NCT04660903

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

November 22, 2020

Last Update Submit

June 8, 2022

Conditions

Fistula in AnoTranssphincteric Anal Fistula

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Postoperative complication

    Possible complications linked to index operation

    3 months after index operation

  • Postoperative complication

    Possible complications linked to index operation

    12 months after index operation

Secondary Outcomes (7)

  • Functional effects

    3 months after index operation

  • Functional effects

    3 months after index operation

  • Functional effects

    12 months after index operation

  • Functional effects

    12 months after index operation

  • Injected fat quantity

    During index operation

  • +2 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

One arm study - the intervention arm is the only actual

Procedure: Autologous fat cell transplantation

Interventions

Autologous fat cell transplantationPROCEDURE

Up to 75 ml of fatty tissue mixture fluid

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Verified perianal or rectovaginal fistula
  • Healthy individuals that can be accepted for an elective operation with total anesthesia.
  • Signed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (6)

  • 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.

    PMID: 28567691BACKGROUND

  • 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.

    PMID: 29285682BACKGROUND

  • 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.

    PMID: 22706128BACKGROUND

  • 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.

    PMID: 30664554BACKGROUND

  • 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.

    PMID: 18766062BACKGROUND

  • 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.

    PMID: 25710946BACKGROUND

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Wilhelm Graf, Professor

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 22, 2020

First Posted

December 9, 2020

Study Start

October 1, 2020

Primary Completion

October 30, 2023

Study Completion

February 28, 2024

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

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

Locations

SE(1)