The Prevalence of Appendiceal Tumours in Periappendicular Abscess

NCT04634448 | Not Yet Recruiting

• 1 other identifier: PeriAPPAC-T
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Appendix Abscess; Appendicitis; Appendix Mass; Appendix Cancer; Appendix Nec; Appendix Tumor; Appendix Diseases

Outcome Measures

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

  2-3 months (interval appendectomy)

Secondary Outcomes (19)

• Tympanic temperature

  Day 0 (on primary admission)

• Imaging (primary diagnosis) finding

  Day 0 (on primary admission)

• Duration of symptoms on admission

  Day 0 (on primary admission)

• Laboratory value: CRP

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

• Laboratory value: leuckocytes

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

Study Arms (2)

Interval appendectomy

OTHER

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.

Procedure: Interval appendectomy

Follow-up MRI

OTHER

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.

Diagnostic Test: Follow-up MRI at 1 year

Interventions

Interval appendectomy PROCEDURE

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

Interval appendectomy

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

Follow-up MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• periappendiceal abscess proven by CT, Mri or US

You may not qualify if:

• patient declines to participate, complicated appendicitis without periappendiceal abscess

Sponsors & Collaborators

• Turku University Hospital: lead
• 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

Related Publications (1)

• Salminen R, Alajaaski J, Rautio T, Hurme S, Nordstrom P, Makarainen E, Lietzen E, Pinta T, Gronroos-Korhonen M, Rantanen T, Andersen J, Mattila A, Kossi J, Riikola A, Paajanen H, Matikainen M, Pokela V, Salminen P. Appendiceal Tumor Prevalence in Patients With Periappendicular Abscess. JAMA Surg. 2025 May 1;160(5):526-534. doi: 10.1001/jamasurg.2025.0312.

  PMID: 40172884 DERIVED

MeSH Terms

Conditions

Appendicitis; Appendiceal Neoplasms

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Paulina Salminen, prof, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Salminen, prof, MD

CONTACT

+35823130000; paulina.salminen@tyks.fi

Jenny Alajääski, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Prospective clinical cohort study

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2035
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion
• Access Criteria: Please see above.