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Crohns DiseaseNCT04940611

A Study of Surgical Interventions in Fistulizing Conditions

An observational study of Crohns Disease and Fistula, run by Takeda at 41 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohns Disease, Fistula, Rectovaginal Fistula
How many people
646 participants
Where
41 sitesin 10 countries
Study dates
5 Aug 2021to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants undergoing surgical interventions to treat fistulas (CPF-CD, CD-RVF and CCF) from surgical and GI specialty sites.

Who may be able to join

  • Participants with CPF-CD
  • 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)
  • Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
Show all 17Show fewer
  • 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:
  • Complex cryptoglandular fistula that meets one or more of the following criteria:
  • Mid or high trans-sphincteric, or
  • Anterior in women, or
  • Horseshoe fistula
  • 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

Who cannot join

  • Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study.
  • Current participation in interventional clinical trials.
  • Has CPF-CD: fistula connection to bladder or another organ
  • Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).

Trial locations and contacts

41 sites in 10 countries.

41 sites in 10 countries

United States13 sites

  • GI Alliance - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • UNC Hospitals

    Chapel Hill, North Carolina, 27599

  • Baylor Research Institute

    Dallas, Texas, 75204

  • Premier Health

    Dayton, Ohio, 45409

  • Colon & Rectal Clinic

    Houston, Texas, 77030

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Vanderbilt University Medical Center- GI Endoscopy Lab

    Nashville, Tennessee, 37212

  • Lenox Hill Hospital PRIME

    New York, New York, 10075

  • Penn Medicine PA

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of South Florida - PARENT

    Tampa, Florida, 33612

Other trials in United States

France7 sites

  • CHRU Hopital Claude Huriez

    Lille, Nord, 59037

  • Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon

    Paris, 75012

  • Hopital Saint Joseph - Paris

    Paris, 75014

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Bouches-du-Rhone, 69310

  • CHU de Rennes - Hopital Pontchaillou

    Rennes, Ille Et Vilaine, 35000

  • CHU de Rouen - Hopital Charles Nicolle

    Rouen, Seine Maritime, 76031

  • Fondation Maison Sante Bagatelle

    Talence, Gironde, 33400

Other trials in France

Belgium5 sites

  • UZ Antwerpen

    Antwerp, 2650

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Jessa Ziekenhuis Hospital

    Hasselt, 3500

  • Clinique CHC MontLegia

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • NH Hospital a.s.Nemocnice Horovice

    Hořovice, 268 31

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

Other trials in Czechia

Israel4 sites

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, 7033001

  • Rambam Health Care Center

    Haifa, 3109601

  • Wolfson Medical Center

    Holon, 58100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

United Kingdom3 sites

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • Royal Victoria Infirmary.

    Newcastle upon Tyne, Tyne & Wear, NE1 4LP

  • Nottingham University Hospital

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

Netherlands2 sites

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ

  • UMC Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

Austria1 site

  • AKH - Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Canada1 site

  • St. Pauls Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Italy1 site

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

About this study

Official title: SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

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.

Read the detailed 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.

Keywords
Drug Therapy
Medical subject headings
Crohn Disease, Fistula, Rectovaginal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04940611
Study groupRoleWhat they receive
Participants With CPF-CDParticipants 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-RVFParticipants 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 CCFParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants who Achieve Clinical Remission of Fistula

    Clinical remission for Complex perianal fistula in Crohn's Disease (CPF-CD) and Complex Cryptoglandular Fistula (CCF) is defined as closure of all index treated external fistula openings that were draining at baseline as assessed clinically despite gentle finger compression. Clinical remission for Rectovaginal fistula with Crohn's Disease (CD-RVF) is defined as epithelization of the index external fistula opening (vaginal opening) compared to baseline.

    Measured: Baseline up to 24 months

Secondary outcomes (5)

  1. Percentage of Participants With Post-surgical Complications

    Post-surgical complications for CPF-CD and CCF is defined as post-index surgery perianal pain, bleeding, infection, urinary retention, delayed or poor wound healing, anal stenosis, and fecal incontinence related to index surgery. Post-surgical complications for CD-RVF is defined as post-index surgery vaginal bleeding, infection, urinary retention, urinary tract infections (UTIs), discharge, delayed or poor wound healing, anal stenosis, fecal incontinence, and pain with intercourse or others related to index surgery.

    Measured: Baseline, 3, 6, 12 and 24 months post-index surgery

  2. Percentage of Participants who Achieve Combined Remission

    Combined remission for CPF-CD and CCF is defined as closure of all index external fistula openings treated with surgery that were draining at baseline as assessed clinically despite gentle finger compression, and absence of fluid collections greater than (>) 2 centimeter (cm) in at least 2 dimensions, as confirmed by pelvic magnetic resonance imaging (MRI) or other imaging procedure. Combined remission for CD-RVF is defined as 100 percent (%) cessation of drainage on both clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) and epithelization of the index external fistula opening (vaginal opening) compared to baseline; and absence of fluid collection as assessed by MRI or other imaging procedure.

    Measured: Baseline, 3, 6, 12 and 24 months post-index surgery

  3. Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula

    Cessation of drainage for CPF-CD and CCF is defined as 100% cessation of drainage from index treated fistula, as assessed clinically. Cessation of drainage for CD-RVF is defined as 100% cessation of drainage on clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) from the index treated fistula.

    Measured: Baseline, 3, 6, 12 and 24 months post-index surgery

  4. Percentage of Participants With Relapse of Fistula in Clinical Remission

    Relapse for CPF-CD and CCF is defined as reopening of any surgically treated index fistulae as clinically assessed; or the development of a perianal fluid collection >2 cm in at least 2 dimensions of the perianal fistula(s) treated, confirmed by MRI assessment or other imaging procedure; or drainage. Relapse for CD-RVF is defined as reopening of any surgically treated index fistulae as clinically assessed; or appearance of fluid collection as assessed by MRI or other imaging procedure; or drainage.

    Measured: Baseline, 3, 6, 12 and 24 months post-index surgery

  5. Percentage of Participants With New Perianal Abscess

    Measured: Baseline, 3, 6, 12 and 24 months post-index surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start5 Aug 2021
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940611
Sponsor's protocol ID
Alofisel-5007
Status last verified
Apr 2026
First submitted
18 Jun 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohns Disease and Fistula, run by Takeda at 41 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, France, Belgium, Czechia, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve Clinical Remission of Fistula (time frame: Baseline up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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