Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial, a Double-blind, Placebo-controlled, Randomized Trial

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas. Study design: The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality. Study population: Men and women of 18 years and older who present for the first time with a perianal abscess. Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets. Main study parameters/endpoints: Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women aged 18 years or older

• Eligible for e-mail questionnaires

• Sufficient understanding of the Dutch written language (reading and writing)

• Obtained written informed consent

Locations
Other Locations
Netherlands
Flevoziekenhuis
RECRUITING
Almere
OLVG
RECRUITING
Amsterdam
University Medical Center location AMC
RECRUITING
Amsterdam
Rode Kruis ziekenhuis
RECRUITING
Beverwijk
Proctos kliniek
RECRUITING
Bilthoven
Amphia hospital
RECRUITING
Breda
IJsselland ziekenhuis
RECRUITING
Capelle Aan Den Ijssel
Albert Schweitzer ziekenhuis
RECRUITING
Dordrecht
Dijklander hospital
RECRUITING
Hoorn
Elisabeth-TweeSteden ziekenhuis
RECRUITING
Tilburg
Diakonessenhuis
RECRUITING
Utrecht
Contact Information
Primary
Ingrid M Han-Geurts, Dr.
i.han@proctoskliniek.nl
030 225 0260
Backup
Justin Y van Oostendorp, Drs.
j.vanoostendorp@proctoskliniek.nl
030 225 0260
Time Frame
Start Date: 2021-12-23
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 298
Treatments
Active_comparator: Antibiotic treatment
Two kinds of antibiotics: Ciprofloxacine 500mg 2dd \& Metronidazole 500mg 3dd
Placebo_comparator: Placebo
Placebo tabletes
Sponsors
Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Leads: dr. IJM Han-Geurts

This content was sourced from clinicaltrials.gov

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