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The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC)

Primary Purpose

Periappendicular Abscess

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interval appendectomy
Follow-up with MRI
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periappendicular Abscess

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-60 years
  • CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful conservative treatment with antibiotic therapy and drainage, if necessary

Exclusion Criteria:

  • Suspicion of a tumour on CT or MRI
  • Age under 18 years or over 60 years
  • Pregnancy or lactating
  • Allergy to contrast media or iodine
  • Renal insufficiency
  • Metformin medication (DM)
  • Unsuccessful initial conservative treatment of periappendicular abscess
  • Lack of co-operation (unable to give consent)
  • A severe medical condition
  • Previous acute appendicitis treated conservatively with antibiotics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Interval Appendectomy

    Follow-up with MRI

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Treatment success
    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

    Secondary Outcome Measures

    Possible appendiceal or colon tumours
    The incidence of possible tumours
    Possible diagnosis of Crohn's disease
    The incidence of possible Crohn's disease
    The length of hospital stay
    Length of hospital stay
    Sick leave
    Sick leave (days)
    Overall morbidity
    Complications related to disease / intervention
    Mortality
    Mortality
    Treatment costs
    Overall treatment costs

    Full Information

    First Posted
    August 19, 2016
    Last Updated
    November 10, 2020
    Sponsor
    Turku University Hospital
    Collaborators
    Oulu University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03013686
    Brief Title
    The Treatment of Periappendicular Abscess After the Acute Phase
    Acronym
    PeriAPPAC
    Official Title
    The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC): a Randomized Clinical Trial Interval Appendectomy Versus Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 15, 2013 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    December 31, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Turku University Hospital
    Collaborators
    Oulu University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periappendicular Abscess

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interval Appendectomy
    Arm Type
    Active Comparator
    Arm 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 Title
    Follow-up with MRI
    Arm Type
    Active Comparator
    Arm 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(s)
    Interval appendectomy
    Intervention Description
    Laparoscopic appendectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Follow-up with MRI
    Intervention Description
    Abdominal MRI
    Primary Outcome Measure Information:
    Title
    Treatment success
    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
    Time Frame
    One year after the intervention
    Secondary Outcome Measure Information:
    Title
    Possible appendiceal or colon tumours
    Description
    The incidence of possible tumours
    Time Frame
    1-10 years
    Title
    Possible diagnosis of Crohn's disease
    Description
    The incidence of possible Crohn's disease
    Time Frame
    1-10 years
    Title
    The length of hospital stay
    Description
    Length of hospital stay
    Time Frame
    up to one year
    Title
    Sick leave
    Description
    Sick leave (days)
    Time Frame
    up to one year
    Title
    Overall morbidity
    Description
    Complications related to disease / intervention
    Time Frame
    Up to 10 years, time points 1, 3, 5 and 10 years
    Title
    Mortality
    Description
    Mortality
    Time Frame
    Up to 10 years
    Title
    Treatment costs
    Description
    Overall treatment costs
    Time Frame
    Up to 10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18-60 years CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful conservative treatment with antibiotic therapy and drainage, if necessary Exclusion Criteria: Suspicion of a tumour on CT or MRI Age under 18 years or over 60 years Pregnancy or lactating Allergy to contrast media or iodine Renal insufficiency Metformin medication (DM) Unsuccessful initial conservative treatment of periappendicular abscess Lack of co-operation (unable to give consent) A severe medical condition Previous acute appendicitis treated conservatively with antibiotics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paulina Salminen, MD, PhD
    Organizational Affiliation
    Turku University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30484824
    Citation
    Mallinen J, Rautio T, Gronroos J, Rantanen T, Nordstrom P, Savolainen H, Ohtonen P, Hurme S, Salminen P. Risk of Appendiceal Neoplasm in Periappendicular Abscess in Patients Treated With Interval Appendectomy vs Follow-up With Magnetic Resonance Imaging: 1-Year Outcomes of the Peri-Appendicitis Acuta Randomized Clinical Trial. JAMA Surg. 2019 Mar 1;154(3):200-207. doi: 10.1001/jamasurg.2018.4373.
    Results Reference
    derived

    Learn more about this trial

    The Treatment of Periappendicular Abscess After the Acute Phase

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