The Prevalence of Appendiceal Tumours in Periappendicular Abscess
NCT04634448 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2020-11-18
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.
Conditions
- Appendix Abscess
- Appendicitis
- Appendix Mass
- Appendix Cancer
- Appendix Nec
- Appendix Tumor
- Appendix Diseases
Interventions
- PROCEDURE
-
Interval appendectomy
interval appendectomy at 2 to 3 months after the initial non-operative treatment
- DIAGNOSTIC_TEST
-
Follow-up MRI at 1 year
follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery
Sponsors & Collaborators
-
Oulu University Hospital
collaborator OTHER -
Tampere University Hospital
collaborator OTHER -
Kuopio University Hospital
collaborator OTHER -
Jyväskylä Central Hospital
collaborator OTHER -
Mikkeli Central Hospital
collaborator OTHER -
Lapland Central Hospital
collaborator UNKNOWN -
Vaasa Central Hospital, Vaasa, Finland
collaborator OTHER -
Seinajoki Central Hospital
collaborator OTHER -
North Karelia Central Hospital
collaborator OTHER -
South Carelia Central Hospital
collaborator OTHER -
Päijänne Tavastia Central Hospital
collaborator OTHER -
Satakunta Central Hospital
collaborator OTHER -
Turku University Hospital
lead OTHER_GOV
Principal Investigators
-
Paulina Salminen, prof, MD · Turku University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-12-01
- Primary Completion
- 2022-12-31
- Completion
- 2035-12-31
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