NCT Number: NCT03803917
Adipose Tissue in Crohn´s Disease Fistulas
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Clinical healing
Time frame: 6 months after 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 outcomes
-
Ceased or reduced fistula secretion
Time frame: 6 months after last injection
Reported by the individual patient
-
Complications to the treatment
Time frame: 6 months after last injection
Reported by the individual patient and findings by clinical examination
Sponsors and collaborators
Lead sponsor
Lilli Lundby
Other
Registry information
Official study title
Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jan 15, 2019
- Registry last updated
- Jan 15, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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