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The Prevalence of Appendiceal Tumours in Periappendicular Abscess (PeriAPPAC-T)

Primary Purpose

Appendix Abscess, Appendicitis, Appendix Mass

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interval appendectomy
Follow-up MRI at 1 year
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendix Abscess

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • periappendiceal abscess proven by CT, Mri or US

Exclusion Criteria:

  • patient declines to participate, complicated appendicitis without periappendiceal abscess

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Interval appendectomy

    Follow-up MRI

    Arm Description

    For all patients presenting with a periappendicular abscess, an interval appendectomy is planned at 2 to 3 months after initial conservative treatment, which is considered mandatory for all patients over 35 years of age. If a patient is under 35 and asymptomatic and does not want to undergo surgery, a follow-up MRI at 1 year will be performed.

    For all patients presenting with a periappendicular abscess, an interval appendectomy is planned at 2 to 3 months after initial conservative treatment, which is considered mandatory for all patients over 35 years of age. If a patient is under 35 and asymptomatic and does not want to undergo surgery, a follow-up MRI at 1 year will be performed.

    Outcomes

    Primary Outcome Measures

    The Prevalence of Appendiceal Tumours in Periappendicular Abscess
    The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study

    Secondary Outcome Measures

    Tympanic temperature
    All patients
    Imaging (primary diagnosis) finding
    All patients
    Duration of symptoms on admission
    All patients
    Laboratory value: CRP
    CRP
    Laboratory value: leuckocytes
    leuk
    Laboratory value: neutrophils
    neutr
    Laboratory value: hemoglobin
    Hb
    Laboratory value: kreatinine
    Krea
    Laboratory value: CEA
    CEA
    Laboratory value. Cg-A
    Cg-A
    Primary nonoperative treatment
    All patients, treatment details
    Colonoscopy: endoscopic findings and histology
    In both intervention groups
    Interval appendectomy specimen histology
    Interval appendectomy patients
    Complications after interval appendectomy
    Clavien-Dindo classification, interval appendectomy group
    Duration of hospital stay
    All patients both at primary treatment, interval appendectomy and follow-up
    Follow-up MRI findings
    In case the patient does not under interval appendectomy
    follow-up CEA
    Follow-up MRI patients
    follow-up CgA
    Follow-up MRI patients
    Surgery after follow-up MRI
    Follow-up with MRI patients

    Full Information

    First Posted
    November 9, 2020
    Last Updated
    November 17, 2020
    Sponsor
    Turku University Hospital
    Collaborators
    Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital, Jyväskylä Central Hospital, Mikkeli Central Hospital, Lapland Central Hospital, Vaasa Central Hospital, Vaasa, Finland, Seinajoki Central Hospital, North Karelia Central Hospital, South Carelia Central Hospital, Päijänne Tavastia Central Hospital, Satakunta Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04634448
    Brief Title
    The Prevalence of Appendiceal Tumours in Periappendicular Abscess
    Acronym
    PeriAPPAC-T
    Official Title
    The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2035 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Turku University Hospital
    Collaborators
    Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital, Jyväskylä Central Hospital, Mikkeli Central Hospital, Lapland Central Hospital, Vaasa Central Hospital, Vaasa, Finland, Seinajoki Central Hospital, North Karelia Central Hospital, South Carelia Central Hospital, Päijänne Tavastia Central Hospital, Satakunta Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Complicated and uncomplicated appendicitis follow different epidemiological trends also suggesting different pathophysiology behind these two different forms of appendicitis. In 3-10% of patients complicated acute appendicitis is enclosed by formation of a circumscribed periappendicular abscess. The clinically established practice of antibiotic therapy and drainage, if necessary, has been shown safe and effective, allowing the acute inflammatory process to subside in more than 90% of cases without surgery. The need of subsequent interval appendectomy has been questioned with appendicitis recurrence risk varying between 5-26%. During trial enrollment in our randomized Peri-APPAC trial based on the interim analysis results with 17% appendiceal tumor rate in the study population, the trial was prematurely terminated based on ethical concerns. All the follow-up group patients were re-evaluated and surgery was offered and recommended to all follow-up group patients. After this assessment and additional appendectomies, two more tumors were diagnosed resulting in neoplasm rate of 20% in the whole study group all diagnosed in patients over 40 years and the neoplasm rate in patients over 40 years was 29%. Based on high appendiceal tumor rate in patients over 40 years, the appendiceal neoplasm rate needs to be further evaluated in prospective patient cohorts undergoing interval appendectomy as interval appendectomy is generally well tolerated and obliterates the risk of missing a possible tumor. In a recent systematic review of retrospective cohort studies with 13.244 acute appendicitis patients the overall appendiceal tumor rate was 1% after appendectomy, but in patients presenting with appendiceal inflammatory mass the neoplasm rate varied from 10% to 29%. This nationwide prospective multicenter cohort study is designed to assess the prevalence of appendiceal tumors associated with a periappendicular abscess. All consecutive patients presenting with a periappendicular abscess are recommended to undergo interval appendectomy after initial conservative treatment with antibiotic therapy and drainage, if necessary. All patients older than 35 years will undergo laparoscopic interval appendectomy at 2 to 3 months and this is also recommended for the patients between 18 and 35 years of age. Asymptomatic patients under 35 years not willing to undergo interval appendectomy, will undergo a follow-up MRI at 1 year after the initial non-operative treatment.
    Detailed Description
    Complicated and uncomplicated appendicitis follow different epidemiological trends also suggesting different pathophysiology behind these two different forms of appendicitis. In 3-10% of patients complicated acute appendicitis is enclosed by formation of a circumscribed periappendicular abscess. The clinically established practice of antibiotic therapy and drainage, if necessary, has been shown safe and effective, allowing the acute inflammatory process to subside in more than 90% of cases without surgery. The need of subsequent interval appendectomy has been questioned with appendicitis recurrence risk varying between 5-26%. During trial enrollment in our randomized Peri-APPAC trial, the high incidence of appendiceal tumors in the study population alarmed the researchers. Based on the interim analysis results with 17% appendiceal tumor rate in the study population, the trial was prematurely terminated based on ethical concerns. All the follow-up group patients were re-evaluated and surgery was offered and recommended to all follow-up group patients. After this assessment and additional appendectomies, two more tumors were diagnosed resulting in neoplasm rate of 20% in the whole study group all diagnosed in patients over 40 years and the neoplasm rate in patients over 40 years was 29%. Based on high appendiceal tumor rate in patients over 40 years, the appendiceal neoplasm rate needs to be further evaluated in prospective patient cohorts undergoing interval appendectomy as interval appendectomy is generally well tolerated and obliterates the risk of missing a possible tumor. In a recent systematic review of retrospective cohort studies with 13.244 acute appendicitis patients the overall appendiceal tumor rate was 1% after appendectomy, but in patients presenting with appendiceal inflammatory mass the neoplasm rate varied from 10% to 29%. This nationwide prospective multicenter cohort study is designed to assess the prevalence of appendiceal tumors associated with a periappendicular abscess. All of the study hospitals will have a common clinical protocol of recommending interval appendectomy to all patients presenting with a periappendicular abscess after initial conservative treatment with antibiotic therapy and drainage, if necessary. Considering the high rate of appendiceal neoplasms, all patients older than 35 years will undergo laparoscopic interval appendectomy at 2 to 3 months after the successful initial non-operative treatment and this is also recommended for the patients between 18 and 35 years of age. Asymptomatic patients under 35 years not willing to undergo interval appendectomy, will undergo a follow-up MRI at 1 year after the initial non-operative treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendix Abscess, Appendicitis, Appendix Mass, Appendix Cancer, Appendix Nec, Appendix Tumor, Appendix Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective clinical cohort study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interval appendectomy
    Arm Type
    Other
    Arm Description
    For all patients presenting with a periappendicular abscess, an interval appendectomy is planned at 2 to 3 months after initial conservative treatment, which is considered mandatory for all patients over 35 years of age. If a patient is under 35 and asymptomatic and does not want to undergo surgery, a follow-up MRI at 1 year will be performed.
    Arm Title
    Follow-up MRI
    Arm Type
    Other
    Arm Description
    For all patients presenting with a periappendicular abscess, an interval appendectomy is planned at 2 to 3 months after initial conservative treatment, which is considered mandatory for all patients over 35 years of age. If a patient is under 35 and asymptomatic and does not want to undergo surgery, a follow-up MRI at 1 year will be performed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Interval appendectomy
    Intervention Description
    interval appendectomy at 2 to 3 months after the initial non-operative treatment
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Follow-up MRI at 1 year
    Intervention Description
    follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery
    Primary Outcome Measure Information:
    Title
    The Prevalence of Appendiceal Tumours in Periappendicular Abscess
    Description
    The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study
    Time Frame
    2-3 months (interval appendectomy)
    Secondary Outcome Measure Information:
    Title
    Tympanic temperature
    Description
    All patients
    Time Frame
    Day 0 (on primary admission)
    Title
    Imaging (primary diagnosis) finding
    Description
    All patients
    Time Frame
    Day 0 (on primary admission)
    Title
    Duration of symptoms on admission
    Description
    All patients
    Time Frame
    Day 0 (on primary admission)
    Title
    Laboratory value: CRP
    Description
    CRP
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
    Title
    Laboratory value: leuckocytes
    Description
    leuk
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
    Title
    Laboratory value: neutrophils
    Description
    neutr
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
    Title
    Laboratory value: hemoglobin
    Description
    Hb
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
    Title
    Laboratory value: kreatinine
    Description
    Krea
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
    Title
    Laboratory value: CEA
    Description
    CEA
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital) and up to 1 year, if no interval appendectomy
    Title
    Laboratory value. Cg-A
    Description
    Cg-A
    Time Frame
    Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)and up to 1 year, if no interval appendectomy
    Title
    Primary nonoperative treatment
    Description
    All patients, treatment details
    Time Frame
    Day 0 and up to one week
    Title
    Colonoscopy: endoscopic findings and histology
    Description
    In both intervention groups
    Time Frame
    2 weeks to 2 months prior to planned interval appendectomy
    Title
    Interval appendectomy specimen histology
    Description
    Interval appendectomy patients
    Time Frame
    At 3 months
    Title
    Complications after interval appendectomy
    Description
    Clavien-Dindo classification, interval appendectomy group
    Time Frame
    at the time of surgery
    Title
    Duration of hospital stay
    Description
    All patients both at primary treatment, interval appendectomy and follow-up
    Time Frame
    up to 2 years
    Title
    Follow-up MRI findings
    Description
    In case the patient does not under interval appendectomy
    Time Frame
    at 1 year
    Title
    follow-up CEA
    Description
    Follow-up MRI patients
    Time Frame
    at 1 year
    Title
    follow-up CgA
    Description
    Follow-up MRI patients
    Time Frame
    at 1 year
    Title
    Surgery after follow-up MRI
    Description
    Follow-up with MRI patients
    Time Frame
    up to 10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: periappendiceal abscess proven by CT, Mri or US Exclusion Criteria: patient declines to participate, complicated appendicitis without periappendiceal abscess
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paulina Salminen, prof, MD
    Phone
    +35823130000
    Email
    paulina.salminen@tyks.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jenny Alajääski, MD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paulina Salminen, prof, MD
    Organizational Affiliation
    Turku University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD is available from the PI upon request, if needed.
    IPD Sharing Time Frame
    At study completion
    IPD Sharing Access Criteria
    Please see above.

    Learn more about this trial

    The Prevalence of Appendiceal Tumours in Periappendicular Abscess

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