Clinical Trials Logo

Clinical Trial Summary

Most perianal abscesses (PA) result from an infection originating in anal crypts that extend into anal glands in the intersphincteric plane. Patients commonly present to the ER and usually require surgical intervention, which poses a burden on the healthcare system. If left undrained, a PA can expand into the adjacent tissues as well as progress to systemic infection. One of the major complications of PA are perianal fistulae; the creation of a tract between the anal canal and the perianal skin that is lined with granulation tissue or skin cells. Up to 1/3 of patients with a PA will develop a fistula; which occurs if a PA drains spontaneously through the perianal skin, and the infection becomes chronic. If this happens, surgical intervention is needed and abscesses may reoccur. Post incision and drainage (I&D) antibiotics in PA have been used to address complications but their use is still controversial and there are no specific recommendations on their use to prevent the formations of fistulae. Recent findings from a systematic review (6 studies, N=817 patients) published in 2019 demonstrated that antibiotic use following I&D of PA was associated with a 36% lower odds of fistula formation, though the quality of the evidence was low. As there are no established prophylactic treatments for fistulae, and because they are difficult to treat, further study of this simple intervention seems warranted. In this trial, adults with a PA requiring I&D will be randomly assigned to receive standard of care with antibiotics or standard of care without antibiotics after I&D. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest are incidence of fistula formation (defined as drainage of the perianal region at or after 2 months), need for re-intervention (i.e., any intervention on the perianal region), quality of life, healthcare utilization, healing time and mortality.

Clinical Trial Description

The development of perianal abscesses is relatively common with an estimated incidence in the UK of 40 per 100,000 habitants (Canadian incidence unknown). It is uncertain if there is any benefit to using prophylactic antibiotics after incision and drainage of a perianal abscess in order to reduce the formation of fistulae, the need for re-intervention, health system costs, and healing time. Further research from high-quality RCTs is needed to establish a benefit, if any, for this practice. Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives: 1. To assess our ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year. 2. To assess our ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program design platform, over the course of one year. 3. To assess our ability to collect complete data directly from participants (patients and clinicians) on: re-intervention, fistula formation, quality of life, and healing time over the course of one year. 4. To examine our ability to carry out data linkages using the IMPACTS Program design platform over the course of one year. 5. To estimate the incidence of fistula formation to inform the sample size calculation for the definitive trial. Study design: This is a multicentre, pragmatic, open label, three-arm parallel-group Vanguard feasibility randomized controlled trial. Adult patients with perianal abscesses requiring incision and drainage will be randomized to receive standard of care with antibiotics or standard of care without antibiotics after incision and drainage. If feasibility is demonstrated during the pilot trial, we will plan to conduct a definitive trial. If there are only minimal changes to the protocol, we will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04549311
Study type Interventional
Source Sunnybrook Health Sciences Centre
Status Active, not recruiting
Phase Phase 3
Start date November 18, 2021
Completion date April 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03913572 - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Terminated NCT01623453 - Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211) N/A
Recruiting NCT04847739 - Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) Phase 2
Completed NCT06314945 - Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula
Completed NCT03763981 - Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula N/A
Not yet recruiting NCT05626023 - A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease Phase 1/Phase 2
Completed NCT01021774 - Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery N/A
Recruiting NCT04519671 - Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease Phase 1/Phase 2
Completed NCT03555773 - Micro-fragmented Adipose Tissue and Complex Crohns' Anal Fistulas N/A
Recruiting NCT03707769 - TIPS Microspheres for Perianal Fistula N/A
Completed NCT03803917 - Adipose Tissue in Crohn´s Disease Fistulas N/A
Recruiting NCT03322488 - Fistulodesis Pilot Study for Closure of Perianal Fistulae N/A
Withdrawn NCT03014219 - Phase 1 Crohn's Pediatric Sub-study of MSC AFP Phase 1
Completed NCT03209700 - Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas Phase 1
Completed NCT03981939 - Perianal Fistula (PAF) Validation and Burden of Illness Study
Recruiting NCT05721794 - Comparative Accuracy of Transperineal Ultrasound (TPUS) Versus Magnetic Resonance Imaging (MRI) for the Assessment of Perianal Fistulae in Patients With Crohn's Disease (CD): a Prospective Observational Longitudinal Cohort Study
Enrolling by invitation NCT03861689 - Tight Control Management in Perianal Crohn's Disease N/A
Not yet recruiting NCT05709717 - Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
Completed NCT02589119 - Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP) Phase 1
Completed NCT04834609 - Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas N/A