The Prevalence of Appendiceal Tumours in Periappendicular Abscess

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTurku University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

periappendiceal abscess proven by CT, Mri or US

Disqualifiers

patient declines to participate, complicated appendicitis without periappendiceal abscess

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interval appendectomy

    Procedure/Surgery

    interval appendectomy at 2 to 3 months after the initial non-operative treatment

  • Follow-up MRI at 1 year

    Diagnostic test

    follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Interval appendectomyOther 1 intervention
Group B: Follow-up MRIOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2-3 months (interval appendectomy)

Secondary outcomes

1

Tympanic temperature

All patients

Time frame
Day 0 (on primary admission)
2

Imaging (primary diagnosis) finding

All patients

Time frame
Day 0 (on primary admission)
3

Duration of symptoms on admission

All patients

Time frame
Day 0 (on primary admission)
4

Laboratory value: CRP

CRP

Time frame
Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

Oulu University Hospital

Collaborator

Tampere University Hospital

Collaborator

Kuopio University Hospital

Collaborator

Jyväskylä Central Hospital

Collaborator

Mikkeli Central Hospital

Collaborator

Lapland Central Hospital

Collaborator

Vaasa Central Hospital, Vaasa, Finland

Collaborator

Seinajoki Central Hospital

Collaborator

North Karelia Central Hospital

Collaborator

South Carelia Central Hospital

Collaborator

Päijänne Tavastia Central Hospital

Collaborator

Satakunta Central Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: