Perianal fistula (cryptoglandular origin)
Conditions
Interventions
None listed
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: • In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. • The subjects sign and date a written, informed consent form. • Participants aged above 18 years. • Patients with transsphincteric cryptoglandular perianal fistula with only one internal opening (or a second opening directly adjacent) with the indication to undergo a TAFR. Transsphincteric fistula was defined as either recurrent fistula with a history of prior surgi-cal intervention(s) or high transsphincteric course with or without multiple tracts.
Exclusion criteria
Exclusion criteria: • Presence of pelvic sepsis at the time of study entry or unexpectedly at time of reconstruc-tive surgery. • Perianal fistula is a rectovaginal fistula. • Presence of an immune compromised status due to systemic autoimmune disease and/or immunosuppressive therapy within 6 months of study entry. • History of or newly diagnosed inflammatory bowel disease during study period. • Presence of haematological and coagulation disorder(s) (trombopathy, thrombophilia, thrombocytopenia, leukaemia). • Any oncological event in the patient’s history in the previous five years. • Diagnosis of HIV infection with inadequate CD4+ count and high viral load. • Pregnant and/or breastfeeding women. • Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete clinical and radiographical closure of the fistula tract after surgical intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Postoperative complications (infection / bleeding) of the perianal and liposuction sites. - Operation data - Length of stay in the hospital - Need of re-intervention and/or readmissions within 12 months follow-up | — |
Contacts
Public ContactJeanine Arkenbosch
Erasmus MC
Outcome results
None listed