Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 4:28 PM
NCT ID:
NCT01290666
Eligibility Criteria:
Inclusion Criteria:
* Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure
* Likely cryptoglandular origin
* Must be at least 18 years of age
* Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable
* Patients willing and able to submit to postoperative follow-up evaluations
Exclusion Criteria:
* Crohn's Disease
* Evidence of on-going local infection
* History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT
* Superficial fistulas without any muscle involvement
* Fistulae of traumatic origin, including obstetric
* Intersphincteric fistulas that would be candidate for fistulotomy
* Horseshoe or multi-tract fistulas
* Ano-vaginal or recto-vaginal fistulas
* Anastomotic fistulas (ileo-anal, colo-anal)
* A wound-healing or autoimmune disorder (including insulin-dependent diabetics)
* Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy
* Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate
* History of prior or current pelvic radiation
* Difficulty comprehending or complying with the study (in surgeon's opinion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01290666
Study Brief:
Protocol Section:
NCT01290666