Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04549311 |
| Other study ID # |
CTO Project ID: 2122 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 18, 2021 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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).
