Clinical trial NCT03882632: Fat Grafting Technique for Fecal Incontinence
Official title: Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Brown Physicians, Inc.
Sponsor class: OTHER
Collaborators: name: Lifespan
First posted: 2019-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fecal Incontinence affects an estimated 2-20% of the general population, and up to 50% of the elderly and institutionalized population. Patients with incontinence tend to suffer in silence; they often do not seek help because of embarrassment and stigma. They often become confined to their homes because they are afraid of having an "accident". Although this is not a life-threatening condition, the psychological, emotional, and social impact can be devastating.

Detailed description: The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with fecal incontinence. Our hypothesis is that placing approximately up to 90 cc of Lipogems® will yield an effective increase in surviving material (over normal fat injection) due to the refinement of the process and result in decreased fecal incontinence over the long term.

Human Adipose Tissue (Fat) possesses regenerative properties in its stromal vascular fraction (SVF). SVF contains nests of pericytes and human MSC mesenchymal stem cells). MSCs are multipotent cells (also called stromal multipotent cells), that possess the ability to differentiate into various tissues, such as bone, tendon, articular cartilage, ligaments, muscle, and fat. Upon fragmentation of adipose tissue using Lipogems®, viable elements are preserved with pericyte identity within an intact stromal vascular niche. It is hypothesized that upon trauma or disruption of this adipose tissue, the regenerative cells within the intact perivascular niche interact via micro vesicles with the microenvironment at the transplant site to promote angiogenesis, neuronal sprouting and fibroblast production thereby stimulating increased vasculature (circulation, nerve regeneration, muscle growth and tone in the urethral sphincter and in the urethral muscles). If these changes are observed, long lasting regenerative changes occur and should be long lasting versus the shorter live effects of the bulking effect by undisrupted fat tissue.

This is a pilot study of 10 subjects will be treated with local injections of Lipogems® and followed for up to two years. Subjects will receive a full history and examination by a single colorectal surgeon. A clear history of their incontinence frequency, Wexner Incontinence Score, Fecal Incontinence Quality of Life Scale, surgical history, and childbirth history will be collected for all registered patients in order to categorize the study participant according to incontinence-type.

All patients will undergo anal physiology testing and endoanal ultrasound. Pre and post measurements will be recorded and compared for objective evaluation. Patients will be evaluated subjectively with the Wexner incontinence Score and Fecal Incontinence Quality of Life Scale.

Patients will have the opportunity to undergo adipose tissue harvesting and targeted local Injection under ultrasound guidance in muscle defects in the intersphincteric space, all around the remaining portions of the external anal sphincter, and along the course of the pudendal nerves bilaterally. This will be done in the procedure room or operating room with IV sedation and local anesthesia. This will all occur in the same setting on the same day.

Eligibility criteria: Inclusion Criteria:

1. Age: \>18 \< 65 years
2. Sex: females
3. Affected by fecal incontinence (moderate to severe) independently from the etiology and previous treatments
4. No restrictions to follow-up for 24 months after treatment
5. Willing and able to provide informed consent

Exclusion Criteria:

1. Present diagnosis of cancer (not in remission)
2. Patients with uncorrected rectal prolapse
3. Overflow incontinence
4. Patients with neurogenic bowel or spinal cord injuries
5. Any patients unable to give informed consent, including members of vulnerable populations
6. Patients with concomitant pelvic floor disorders, like paradoxical puborectalis contraction or pelvic floor dysfunction
7. Chronic diarrhea
8. Patients with chronic steroid use
9. Patients 17 and under
10. Anal Sepsis (abscess and/or fistula)
11. Inability to undergo the intended diagnostic tests and follow-up
12. Pregnancy
13. Diagnosis of Diabetes Mellitus 1 and 2

Primary outcomes:
measure: Resolution of Fecal Incontinence Measured by patient reported outcomes on questionnaires
timeFrame: 2 years
measure: Resolution of Fecal Incontinence Measured by Physical Exam
timeFrame: 2 years
Secondary outcomes:
measure: Incident of treatment related adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Lifespan
state: Rhode Island
Study officials:
References: