A Study of Surgical Interventions in Fistulizing Conditions

Takeda

Status: Active, not recruiting

Conditions: Complex Perianal Fistula; Complex Cryptoglandular Fistula; Fistula; Crohns Disease; Rectovaginal Fistula

Study type: Observational

Funder types: Industry

Identifiers

NCT04940611

Alofisel-5007

Details and patient eligibility

About

In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.

The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Full description

This is a non-interventional, prospective study of participants with complex fistulizing conditions (CPF-CD, CD develops CD-RVF and CCF) who are currently undergoing surgical intervention in the real world clinical setting.

The study will enroll approximately 750 participants. The data will be collected prospectively at the study sites and will be recorded into electronic data capture forms (EDCs). Participants will be enrolled to the following observational cohorts:

• Participants With CPF-CD
• Participants With CD-RVF
• Participants With CCF

This multi-center study will be conducted in the United States, Canada, Europe, and Israel. Participants undergoing surgical interventions to treat fistulas will be enrolled from surgical and gastrointestinal (GI) specialty sites. The overall duration of the study will be 24 months. Data will be collected at baseline with follow-up information collected approximately every 3 to 6 months.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants with CPF-CD

1. CPF-CD that meets one or more of the following criteria:

   • High inter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric fistula, or
   • Presence of greater than or equal to (>=) 2 external openings, or
   • Associated perianal abscess(es)

2. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

   • Fistulotomy, fistula plug, fibrin glue, advancement flap (AF), ligation of inter-sphincteric fistula tract (LIFT), flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton for palliative purposes.

Participants with CD-RVF: Rectovaginal fistula per physician diagnosis

1. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

• Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, gracilis muscle interposition/tissue grafts, martius procedure, abdominal procedures, other; and seton use for palliative purposes.

Participants with CCF:

1. Complex cryptoglandular fistula that meets one or more of the following criteria:

   • Mid or high trans-sphincteric, or
   • Anterior in women, or
   • Horseshoe fistula

2. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

   • Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton use for palliative purposes

Exclusion criteria

Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study.

1. Current participation in interventional clinical trials.
2. Has CPF-CD: fistula connection to bladder or another organ
3. Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).

Trial design

750 participants in 3 patient groups

Participants With CPF-CD

Description:

Participants diagnosed with CPF-CD will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.

Participants With CD-RVF

Description:

Participants diagnosed with CD-RVF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.

Participants With CCF

Description:

Participants diagnosed with CCF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.