Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
65 participants
INTERVENTIONAL
2006-01-31
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%.
Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
NCT00450671
Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
NCT00830661
Glue Application in the Treatment of Low-Output Fistulas
NCT01828892
Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation
NCT04660903
Anal Fistula Plug, a Retrospective Study
NCT04319861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up.
Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the two groups
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
glue (Tissucol ) treatment
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
glue (Tissucol) treatment
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
Fistula closing with biological glue
After cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it
Seton treatment
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
transsphincteric Seton positioning
A cutting seton is applied into the fistula tract
Seton positioning into the fistula tract
Under spinal anesthesia a Seton is positioned into the fistula tract.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transsphincteric Seton positioning
A cutting seton is applied into the fistula tract
glue (Tissucol) treatment
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
Fistula closing with biological glue
After cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it
Seton positioning into the fistula tract
Under spinal anesthesia a Seton is positioned into the fistula tract.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* anal abscesses
* complex fistulas (horse-shoe type or multiple secondary tracts)
* immunosuppression
* diabetes,
* anal fissures
* pregnancy
* anti-coagulant treatments,
* any allergic reaction to the bioglue components.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Societa Italiana di Chirurgia ColoRettale
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Italian Society of Colorectal surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donato F Altomare, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bari
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept of Emergency and Organ transplantation - University of Bari
Bari, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SICCR 10/2006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.