Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial

NCT05385887 | Unknown DMC

• 2 other identifiers: NL75540.018.202020-004449-35
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 11

Brief Summary

Rationale: Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\\ 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.

Conditions

Perianal Fistula; Perianal Abscess; Drain Abscess

Keywords

antibiotics; antibiotic treatment; perianal fistula; perianal abscess; drainage of abscess

Outcome Measures

Primary Outcomes (1)

• Perianal fistula at 1 year follow up

  A perianal fistula is diagnosed based on findings from physical examination or by a telephone call after 12 months were the doctor asks for symptoms as serosanguinous discharge and pain. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed. So: yes/no fistula (dichotomous parameter)

  1 year

Secondary Outcomes (8)

• Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating.

  1 year

• In-hospital direct and indirect costs and out-of hospital posteroperative costs

  1 year

• Need of repeated drainage

  1 year

• PROMs

  1 year

• Day of discharge from hospital

  1 year

Study Arms (2)

Antibiotic treatment

ACTIVE COMPARATOR

Two kinds of antibiotics: Ciprofloxacine 500mg 2dd \& Metronidazole 500mg 3dd

Drug: Ciprofloxacin 500 mg; Drug: Metronidazole 500 mg

Placebo

PLACEBO COMPARATOR

Placebo tabletes

Drug: Placebo

Interventions

Ciprofloxacin 500 mg DRUG

One tablet of 500mg Ciprifloxacine, twice a day

Antibiotic treatment

Metronidazole 500 mg DRUG

One tablet of 500mg Metronidazole, three times a day

Antibiotic treatment

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A coexistent anorectal fistula
• Secondary or recurrent anorectal abscess
• Presence of an internal fistula opening
• Any additional surgical procedure performed during the same session
• Previous (peri)anal surgery
• Inflammatory bowel disease
• History of radiation of the pelvic area
• Anorectal malignancy
• Immunodeficiency
• Kidney failure (eGFR \<30ml/min)
• Valvular heart disease
• Pregnancy or lactation
• Postoperative antibiotic prophylaxis indicated for another reason
• Immunosuppressive medication at the time of surgery
• Allergy to metronidazole or ciprofloxacin

Sponsors & Collaborators

• dr. IJM Han-Geurts: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (11)

Amphia hospital

Breda, North Brabant, 4818 CK, Netherlands

RECRUITING

Elisabeth-TweeSteden ziekenhuis

Tilburg, North Brabant, 5022 GC, Netherlands

RECRUITING

OLVG

Amsterdam, North Holland, 1091 AC, Netherlands

RECRUITING

Rode Kruis ziekenhuis

Beverwijk, North Holland, 1942 LE, Netherlands

RECRUITING

Dijklander hospital

Hoorn, North Holland, 1624 NP, Netherlands

RECRUITING

Albert Schweitzer ziekenhuis

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

Proctos kliniek

Bilthoven, Utrecht, 3723 MB, Netherlands

RECRUITING

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

University Medical Center location AMC

Amsterdam, Netherlands

RECRUITING

IJsselland ziekenhuis

Capelle aan den IJssel, Netherlands

RECRUITING

Diakonessenhuis

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• van Oostendorp JY, Dekker L, van Dieren S, Bemelman WA, Han-Geurts IJM. Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial. BMJ Open. 2022 Nov 8;12(11):e067970. doi: 10.1136/bmjopen-2022-067970.

  PMID: 36351727 DERIVED

MeSH Terms

Interventions

Ciprofloxacin; Metronidazole

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ingrid M Han-Geurts, Dr.

CONTACT

030 225 0260; i.han@proctoskliniek.nl

Justin Y van Oostendorp, Drs.

CONTACT

030 225 0260; j.vanoostendorp@proctoskliniek.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patiënt, clinician and investigators are all blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: double-blind, placebo-controlled, randomized trial

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 23, 2022
• Study Start: December 23, 2021
• Primary Completion: December 31, 2024
• Study Completion: August 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within one year after the last study visit of the last patient. Data will be availabe for 15 years.

Locations

NL (11)