NCT04634448: PeriAPPAC-T

The Prevalence of Appendiceal Tumours in Periappendicular Abscess

Not yet recruiting NA Last updated 18 November 2020

What this trial tests

NA trial testing Interval appendectomy in Appendix Abscess in 400 participants. Not yet recruiting.

Timeline

1 December 2020

Primary endpoint
31 December 2022

31 December 2035

Quick facts

Lead sponsor	Turku University Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	1 December 2020
Primary completion	31 December 2022
Estimated completion	31 December 2035

Drugs / interventions tested

• Interval appendectomy
• Follow-up MRI at 1 year

Conditions studied

• Appendix Abscess — all drugs for Appendix Abscess →
• Appendicitis — all drugs for Appendicitis →
• Appendix Mass — all drugs for Appendix Mass →
• Appendix Cancer — all drugs for Appendix Cancer →

Sponsor

Turku University Hospital

Who can join

18 and older, any sex, with Appendix Abscess or Appendicitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Appendiceal Tumor Prevalence in Patients With Periappendicular Abscess.
   Salminen R, Alajääski J, Rautio T, Hurme S, et al · · 2025 · cited 7× · PMID 40172884 · DOI 10.1001/jamasurg.2025.0312