Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula (AdiTiF)

Hospital Mutua de Terrassa

Status

Enrolling

Conditions

Anal Fistula

Treatments

Procedure: Injection of autologous freshly collected adipose tissue

Procedure: sham

Study type

Interventional

Funder types

Other

Identifiers

NCT04790123

P19/035

Details and patient eligibility

About

The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its treatment remains a real challenge due to the limited efficacy of sphincter preservation techniques and the inevitable risk of faecal incontinence in those cases that require surgery. Goals: To evaluate the efficacy and safety of the injection of freshly collected autologous adipose tissue as a minimally invasive, highly reproducible alternative, without risk for the continence of the patient, and of very low cost, in the treatment of complex cryptoglandular anal fistula. Methodology: Prospective multicenter, randomized, double-blinded, parallel-group, placebo-controlled clinical trial. Randomization list for each center to ensure the balance of inter-center allocation. Patients older than 18 years with cryptoglandular anal fistula with suppuration for more than 6 weeks and less than 1 year, who have received at most: curettage and drainage placement will be included. Treatment group: injection of fresh autologous fat into the fistulous tract, after curettage and closure of the internal orifice, and after lipoaspirate fat in the abdomen and centrifugation thereof. Placebo group: curettage and closure of the internal orifice and simulated intervention in the abdomen. Evaluation: protocolized clinical history and fistula complexity score (CFS), subjective perception of its pathology, St.Marks continence score, Quality of life questionnaire (QoLAF), and endoanal 3D ultrasound, at baseline, at one week, and at 3, 6 and 12 months after the intervention. The patients and the evaluator will be blind to the treatment. Patients who cannot end up receiving treatment due to intraoperative incidents or medical decision will be excluded from the study (post randomization exclusion). In each center there will be a blind evaluator to perform the follow-ups and endoanal ultrasound.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 18 years
Anal fistula with suppuration for more than 6 weeks and less than 1 year, that have not received any previous treatment or at most: curettage and drainage placement
Complex cryptoglandular anal fistula: medium or high transsphincteric fistula, suprasphincteric fistula and extra sphincter fistula, shown by endoanal ultrasound.
Low transsphincteric fistulas in patients with fecal incotinence.
Any cryptoglandular anal fistula with risk factors for anal incontinence: anterior location fistula in women, history of pelvic surgery (hysterectomy, rectal resection), history of pelvic radiotherapy or previous anal surgery
Draining with Seton placed >2 weeks before surgery and present at the time of treatment
Disposition and ability to comply with the study protocol
Signed informed consent

Exclusion criteria

Patients diagnosed with inflammatory bowel disease
Previous history of perianal fistula treated with any surgery different than curettage and seton placement (this include any type of surgery with curative intention, i.e. flap, lift technique, Radiofrequency, laser, stem cells, Filac, etc)
Presence of Rectovaginal fistula
Technical impossibility for lipoaspirate (liposuction) technique.
Presence of perianal collections larger than 2cm
Presence of several paths from 1 internal hole only
Presence of secondary fistula paths or tracts
Perianal surgery necessary at the time of planning the fistula treatment, for reasons other than fistula.
Major surgery needed within 28 days of recruitment
Immunomodulator treatment or corticotherapy in a previous period of 6 months
Stoma patients
Serious medical or psychiatric illness that requires frequent hospitalization.
Pregnancy, pregnancy plans or breastfeeding in the next 12 months
Active smokers, or ex-smokers of less than 3 months