The Prevalence of Appendiceal Tumours in Periappendicular Abscess
NCT ID: NCT04634448
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2020-12-01
2035-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interval appendectomy
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.
Interval appendectomy
interval appendectomy at 2 to 3 months after the initial non-operative treatment
Follow-up MRI
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.
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
Interventions
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Interval appendectomy
interval appendectomy at 2 to 3 months after the initial non-operative treatment
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Oulu University Hospital
OTHER
Tampere University Hospital
OTHER
Kuopio University Hospital
OTHER
Jyväskylä Central Hospital
OTHER
Mikkeli Central Hospital
OTHER
Lapland Central Hospital
UNKNOWN
Vaasa Central Hospital, Vaasa, Finland
OTHER
Seinajoki Central Hospital
OTHER
North Karelia Central Hospital
OTHER
South Carelia Central Hospital
OTHER
Päijänne Tavastia Central Hospital
OTHER
Satakunta Central Hospital
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Paulina Salminen
Professor of Surgery
Principal Investigators
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Paulina Salminen, prof, MD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Central Contacts
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Jenny Alajääski, MD
Role: CONTACT
References
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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.
Other Identifiers
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PeriAPPAC-T
Identifier Type: -
Identifier Source: org_study_id