Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection (Fistula_CM1)
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| ClinicalTrials.gov Identifier: NCT04750499 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2021
Last Update Posted : February 28, 2024
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | February 8, 2021 | |||||||||
| First Posted Date ICMJE | February 11, 2021 | |||||||||
| Last Update Posted Date | February 28, 2024 | |||||||||
| Actual Study Start Date ICMJE | September 1, 2020 | |||||||||
| Estimated Primary Completion Date | September 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Healing rate [ Time Frame: 1 year ] Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.
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| Original Primary Outcome Measures ICMJE |
Healing [ Time Frame: 1 year ] Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection | |||||||||
| Official Title ICMJE | Treatment of Complex Perianal Fistulas, in Patients Without Crohn's Disease, by Endorectal Advancement Flap Associated With Injection of Autologous and Micro-fragmented Adipose Tissue | |||||||||
| Brief Summary | The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease. | |||||||||
| Detailed Description | Treatment of anal fistula pursues permanent healing and preservation of anal continence, not always easy goals in complex anal fistulas. In patients with Crohn's disease, simple surgery (ligation of the path and suturing of the internal orifice) associated with injections of stem cells derived from autologous or allogeneic adipose tissue has been shown to cure up to 70%. of the cases. Similar results have been obtained in small series of patients with fistulas of cryptoglandular origin and also in rectourethral and rectovaginal fistulas of other etiologies. Unfortunately, this treatment is time consuming and extremely expensive. Fresh adipose tissue is an alternative source of mesenchymal stem cells (MSC) with regenerative capabilities, immunomodulatory angiogenic and anti-inflammatory effects. The injection of fresh adipose tissue, obtained by liposuction from the same patient, is currently a therapeutic alternative used in regenerative medicine, plastic and orthopedic surgery indications, as well in other fields. Beneficial effects of fresh adipose tissue on anus fistulas and fecal incontinence have also been reported. The aim of the present study is to evaluate the effectiveness of the injection of autologous, microfragmented and minimally manipulated adipose tissue, associated with a surgical technique that obtains by itself up to 70% cure in order to add the benefits of surgery with those in regenerative medicine hoping that the beneficial effects of MSC will aid in the healing and repair process. A prospective study is proposed in 12 patients with non-Crohn's-related complex anals fistulas. Whenever possible, the endorectal advancement flap technique will be applied; in blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Interventional (Clinical Trial) Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Anal Fistula | |||||||||
| Intervention ICMJE | Procedure: Adipose tissue injection associated with endorectal advancement flap.
Injection of adipose tissue will be associated with endorectal advancement flap technique. In blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.
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| Study Arms ICMJE | Experimental: Treatment
Patients with complex anal fistulas, non related to Crohn's disease.
Intervention: Procedure: Adipose tissue injection associated with endorectal advancement flap.
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
12 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | September 2024 | |||||||||
| Estimated Primary Completion Date | September 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04750499 | |||||||||
| Other Study ID Numbers ICMJE | Fistula_CM1 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Hospital Clinic of Barcelona | |||||||||
| Original Responsible Party | Hospital Plató | |||||||||
| Current Study Sponsor ICMJE | Hospital Clinic of Barcelona | |||||||||
| Original Study Sponsor ICMJE | Hospital Plató | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Hospital Clinic of Barcelona | |||||||||
| Verification Date | February 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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