<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03013686</url>
  </required_header>
  <id_info>
    <org_study_id>PeriAPPAC</org_study_id>
    <nct_id>NCT03013686</nct_id>
  </id_info>
  <brief_title>The Treatment of Periappendicular Abscess After the Acute Phase</brief_title>
  <acronym>PeriAPPAC</acronym>
  <official_title>The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC): a Randomized Clinical Trial Interval Appendectomy Versus Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic&#xD;
      appendectomy with follow-up MRI in patients with initially successfully treated&#xD;
      periappendicular abscess.&#xD;
&#xD;
      Periappendicular abscess is generally initially treated conservatively with antibiotic&#xD;
      therapy and if necessary, drainage. Operative treatment in the acute abscess phase is&#xD;
      associated with increased morbidity and thus complicated appendicitis with a periappendicular&#xD;
      abscess is initially treated conservatively. However, there is debate on whether interval&#xD;
      appendectomy is required.&#xD;
&#xD;
      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular&#xD;
      abscess, patients enrolled in the PeriAPPAC study are randomised either to interval&#xD;
      appendectomy or to follow-up with MRI at two months after the initial treatment. All patients&#xD;
      also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the&#xD;
      MRI (outpatient visit at endoscopy unit with information on the MRI).&#xD;
&#xD;
      The primary endpoint is the treatment success in both treatment arms. In the interval&#xD;
      appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up&#xD;
      treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year&#xD;
      follow-up.&#xD;
&#xD;
      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku&#xD;
      University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University&#xD;
      Hospital and Seinäjoki Central Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic&#xD;
      appendectomy with follow-up MRI in patients with initially successfully treated&#xD;
      periappendicular abscess.&#xD;
&#xD;
      Periappendicular abscess is generally initially treated conservatively with antibiotic&#xD;
      therapy and if necessary, drainage. Operative treatment in the acute abscess phase is&#xD;
      associated with increased morbidity and thus complicated appendicitis with a periappendicular&#xD;
      abscess is initially treated conservatively. However, there is debate on whether interval&#xD;
      appendectomy is required.&#xD;
&#xD;
      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular&#xD;
      abscess, patients enrolled in the PeriAPPAC study are randomised either to interval&#xD;
      appendectomy or to follow-up with MRI at two months after the initial treatment. All patients&#xD;
      also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the&#xD;
      MRI (outpatient visit at endoscopy unit with information on the MRI).&#xD;
&#xD;
      The primary endpoint is the treatment success in both treatment arms. In the interval&#xD;
      appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up&#xD;
      treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year&#xD;
      follow-up.&#xD;
&#xD;
      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku&#xD;
      University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University&#xD;
      Hospital and Seinäjoki Central Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 15, 2013</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment success</measure>
    <time_frame>One year after the intervention</time_frame>
    <description>Treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and successful appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Possible appendiceal or colon tumours</measure>
    <time_frame>1-10 years</time_frame>
    <description>The incidence of possible tumours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Possible diagnosis of Crohn's disease</measure>
    <time_frame>1-10 years</time_frame>
    <description>The incidence of possible Crohn's disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The length of hospital stay</measure>
    <time_frame>up to one year</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick leave</measure>
    <time_frame>up to one year</time_frame>
    <description>Sick leave (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall morbidity</measure>
    <time_frame>Up to 10 years, time points 1, 3, 5 and 10 years</time_frame>
    <description>Complications related to disease / intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment costs</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Overall treatment costs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Periappendicular Abscess</condition>
  <arm_group>
    <arm_group_label>Interval Appendectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary.&#xD;
Interval appendectomy is performed at two months after the primary treatment, all patients also undergo colonoscopy prior to appendectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Follow-up with MRI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary.&#xD;
The patients undergo abdominal magnetic resonance imaging at two months after the primary treatment, all patients also undergo colonoscopy right after the MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Interval appendectomy</intervention_name>
    <description>Laparoscopic appendectomy</description>
    <arm_group_label>Interval Appendectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Follow-up with MRI</intervention_name>
    <description>Abdominal MRI</description>
    <arm_group_label>Follow-up with MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-60 years&#xD;
&#xD;
          -  CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful&#xD;
             conservative treatment with antibiotic therapy and drainage, if necessary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspicion of a tumour on CT or MRI&#xD;
&#xD;
          -  Age under 18 years or over 60 years&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  Allergy to contrast media or iodine&#xD;
&#xD;
          -  Renal insufficiency&#xD;
&#xD;
          -  Metformin medication (DM)&#xD;
&#xD;
          -  Unsuccessful initial conservative treatment of periappendicular abscess&#xD;
&#xD;
          -  Lack of co-operation (unable to give consent)&#xD;
&#xD;
          -  A severe medical condition&#xD;
&#xD;
          -  Previous acute appendicitis treated conservatively with antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paulina Salminen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Paulina Salminen</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013686
org study id: PeriAPPAC
nct id: NCT03013686
lead sponsor: 
collaborator: 
has dmc: No
The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic
      appendectomy with follow-up MRI in patients with initially successfully treated
      periappendicular abscess.

      Periappendicular abscess is generally initially treated conservatively with antibiotic
      therapy and if necessary, drainage. Operative treatment in the acute abscess phase is
      associated with increased morbidity and thus complicated appendicitis with a periappendicular
      abscess is initially treated conservatively. However, there is debate on whether interval
      appendectomy is required.

      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular
      abscess, patients enrolled in the PeriAPPAC study are randomised either to interval
      appendectomy or to follow-up with MRI at two months after the initial treatment. All patients
      also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the
      MRI (outpatient visit at endoscopy unit with information on the MRI).

      The primary endpoint is the treatment success in both treatment arms. In the interval
      appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up
      treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year
      follow-up.

      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku
      University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University
      Hospital and Seinäjoki Central Hospital.
The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic
      appendectomy with follow-up MRI in patients with initially successfully treated
      periappendicular abscess.

      Periappendicular abscess is generally initially treated conservatively with antibiotic
      therapy and if necessary, drainage. Operative treatment in the acute abscess phase is
      associated with increased morbidity and thus complicated appendicitis with a periappendicular
      abscess is initially treated conservatively. However, there is debate on whether interval
      appendectomy is required.

      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular
      abscess, patients enrolled in the PeriAPPAC study are randomised either to interval
      appendectomy or to follow-up with MRI at two months after the initial treatment. All patients
      also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the
      MRI (outpatient visit at endoscopy unit with information on the MRI).

      The primary endpoint is the treatment success in both treatment arms. In the interval
      appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up
      treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year
      follow-up.

      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku
      University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University
      Hospital and Seinäjoki Central Hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment success
time frame: One year after the intervention
description: Treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and successful appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up
measure: Possible appendiceal or colon tumours
time frame: 1-10 years
description: The incidence of possible tumours
measure: Possible diagnosis of Crohn's disease
time frame: 1-10 years
description: The incidence of possible Crohn's disease
measure: The length of hospital stay
time frame: up to one year
description: Length of hospital stay
measure: Sick leave
time frame: up to one year
description: Sick leave (days)
measure: Overall morbidity
time frame: Up to 10 years, time points 1, 3, 5 and 10 years
description: Complications related to disease / intervention
measure: Mortality
time frame: Up to 10 years
description: Mortality
measure: Treatment costs
time frame: Up to 10 years
description: Overall treatment costs
arm group label: Interval Appendectomy
arm group type: Active Comparator
description: The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary.
Interval appendectomy is performed at two months after the primary treatment, all patients also undergo colonoscopy prior to appendectomy.
arm group label: Follow-up with MRI
arm group type: Active Comparator
description: The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary.
The patients undergo abdominal magnetic resonance imaging at two months after the primary treatment, all patients also undergo colonoscopy right after the MRI.
intervention type: Procedure
intervention name: Interval appendectomy
description: Laparoscopic appendectomy
arm group label: Interval Appendectomy
intervention type: Procedure
intervention name: Follow-up with MRI
description: Abdominal MRI
arm group label: Follow-up with MRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paulina Salminen, MD, PhD
role: Principal Investigator
affiliation: Turku University Hospital
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Paulina Salminen
investigator title: Principal investigator
mesh term: Abscess
sharing ipd: No