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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04634448
Acronym
PeriAPPAC-T
Enrollment
400
Registered
2020-11-18
Start date
2020-12-01
Completion date
2035-12-31
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

DIAGNOSTIC_TESTFollow-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

Oulu University Hospital
CollaboratorOTHER
Tampere University Hospital
CollaboratorOTHER
Kuopio University Hospital
CollaboratorOTHER
Jyväskylä Central Hospital
CollaboratorOTHER
Mikkeli Central Hospital
CollaboratorOTHER
Lapland Central Hospital
CollaboratorUNKNOWN
Vaasa Central Hospital, Vaasa, Finland
CollaboratorOTHER
Seinajoki Central Hospital
CollaboratorOTHER
North Karelia Central Hospital
CollaboratorOTHER
South Carelia Central Hospital
CollaboratorOTHER
Päijänne Tavastia Central Hospital
CollaboratorOTHER
Satakunta Central Hospital
CollaboratorOTHER
Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective clinical cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* periappendiceal abscess proven by CT, Mri or US

Exclusion criteria

* patient declines to participate, complicated appendicitis without periappendiceal abscess

Design outcomes

Primary

MeasureTime frameDescription
The Prevalence of Appendiceal Tumours in Periappendicular Abscess2-3 months (interval appendectomy)The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study

Secondary

MeasureTime frameDescription
Imaging (primary diagnosis) findingDay 0 (on primary admission)All patients
Duration of symptoms on admissionDay 0 (on primary admission)All patients
Laboratory value: CRPDay 0 (on primary admission) up to 3-5 days (discharge from the hospital)CRP
Laboratory value: leuckocytesDay 0 (on primary admission) up to 3-5 days (discharge from the hospital)leuk
Laboratory value: neutrophilsDay 0 (on primary admission) up to 3-5 days (discharge from the hospital)neutr
Laboratory value: hemoglobinDay 0 (on primary admission) up to 3-5 days (discharge from the hospital)Hb
Laboratory value: kreatinineDay 0 (on primary admission) up to 3-5 days (discharge from the hospital)Krea
Laboratory value: CEADay 0 (on primary admission) up to 3-5 days (discharge from the hospital) and up to 1 year, if no interval appendectomyCEA
Laboratory value. Cg-ADay 0 (on primary admission) up to 3-5 days (discharge from the hospital)and up to 1 year, if no interval appendectomyCg-A
Tympanic temperatureDay 0 (on primary admission)All patients
Colonoscopy: endoscopic findings and histology2 weeks to 2 months prior to planned interval appendectomyIn both intervention groups
Interval appendectomy specimen histologyAt 3 monthsInterval appendectomy patients
Complications after interval appendectomyat the time of surgeryClavien-Dindo classification, interval appendectomy group
Duration of hospital stayup to 2 yearsAll patients both at primary treatment, interval appendectomy and follow-up
Follow-up MRI findingsat 1 yearIn case the patient does not under interval appendectomy
follow-up CEAat 1 yearFollow-up MRI patients
follow-up CgAat 1 yearFollow-up MRI patients
Surgery after follow-up MRIup to 10 yearsFollow-up with MRI patients
Primary nonoperative treatmentDay 0 and up to one weekAll patients, treatment details

Contacts

Primary ContactPaulina Salminen, prof, MD
paulina.salminen@tyks.fi+35823130000
Backup ContactJenny Alajääski, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026