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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03803917
Other study ID # AT_ Fistula_observational
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2015
Est. completion date June 30, 2018

Study information

Verified date January 2019
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Present study investigated the efficacy of injection of freshly collected autologous adipose tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by liposuction was injected into the perianal fistulas. Primary objective was complete clinical healing six months after treatment. Secondary objectives were reduced or ceased fistula secretion and complications to the treatment.


Description:

Investigators prospectively registered symptoms, complications and results of treatment in 21 patients with Crohn´s Disease who underwent treatment with freshly harvested autologous adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria consisted of the following: the presence of complex CD fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and extent of the fistula. Clinical examinations of the patients were performed at intervals of six weeks, three months and six months following adipose tissue injection. Primary endpoint was complete fistula healing at clinical examination six months after the last injection. A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination. Secondary endpoints included either reduced or ceased fistula secretion. If clinical healing of the fistula was not obtained six weeks after the first treatment, patients were offered a second adipose injection within two weeks. A third injection was offered to patients who did not have complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all patients with transsphincteric and intersphincteric fistulas who, upon clinical examination, demonstrated complete healing at 6 months after the last injection.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of Crohn´s Disease

- presence of complex Crohn´s Disease fistulas

- fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment.

Exclusion Criteria:

- Fistulas developed following proctectomy were excluded.

Study Design


Intervention

Procedure:
Injection with freshly collected autologous adipose tissue


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lilli Lundby

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical healing A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination 6 months after last injection
Secondary Ceased or reduced fistula secretion Reported by the individual patient 6 months after last injection
Secondary Complications to the treatment Reported by the individual patient and findings by clinical examination 6 months after last injection
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