Recruiting

Fat Grafting

Sponsor:

Melanie Salerno, RN

Code:

NCT03882632

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Fat Grafting for Fecal Incontinence

Study Details

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.

Conditions

Fecal Incontinence

Study ID

NCT03882632

Start date

Apr 11, 2019

Status verified date

Jul, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Apr, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients with Fecal Incontinence

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

Interventions

Fat Grafting for Fecal Incontinence

Autologous adiopse tissue harvesting/grafting using Lipogems

Primary outcome measure

  • Resolution of Fecal Incontinence Measured by patient reported outcomes on questionnaires [ Time Frame: 2 years ]
  • Resolution of Fecal Incontinence Measured by Physical Exam [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Melanie Salerno

4014447148melanie.salerno@brownphysicians.org

Locations

Lifespan

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Melanie Salerno, RN

401-444-7148melanie.salerno@brownphysicians.org

Principal Investigator:

Leslie Roth, MD

More Information

Sponsor

Melanie Salerno, RN

Last update posted

Jul 9, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Melanie Salerno, RN on 2020-07-09.