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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04634448
Other study ID # PeriAPPAC-T
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2035

Study information

Verified date November 2020
Source Turku University Hospital
Contact Paulina Salminen, prof, MD
Phone +35823130000
Email paulina.salminen@tyks.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 31, 2035
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - periappendiceal abscess proven by CT, Mri or US Exclusion Criteria: - patient declines to participate, complicated appendicitis without periappendiceal abscess

Study Design


Intervention

Procedure:
Interval appendectomy
interval appendectomy at 2 to 3 months after the initial non-operative treatment
Diagnostic Test:
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

Locations

Country Name City State
n/a

Sponsors (13)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Tympanic temperature All patients Day 0 (on primary admission)
Secondary Imaging (primary diagnosis) finding All patients Day 0 (on primary admission)
Secondary Duration of symptoms on admission All patients Day 0 (on primary admission)
Secondary Laboratory value: CRP CRP Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary Laboratory value: leuckocytes leuk Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary Laboratory value: neutrophils neutr Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary Laboratory value: hemoglobin Hb Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary Laboratory value: kreatinine Krea Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary Laboratory value: CEA CEA Day 0 (on primary admission) up to 3-5 days (discharge from the hospital) and up to 1 year, if no interval appendectomy
Secondary Laboratory value. Cg-A Cg-A Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)and up to 1 year, if no interval appendectomy
Secondary Primary nonoperative treatment All patients, treatment details Day 0 and up to one week
Secondary Colonoscopy: endoscopic findings and histology In both intervention groups 2 weeks to 2 months prior to planned interval appendectomy
Secondary Interval appendectomy specimen histology Interval appendectomy patients At 3 months
Secondary Complications after interval appendectomy Clavien-Dindo classification, interval appendectomy group at the time of surgery
Secondary Duration of hospital stay All patients both at primary treatment, interval appendectomy and follow-up up to 2 years
Secondary Follow-up MRI findings In case the patient does not under interval appendectomy at 1 year
Secondary follow-up CEA Follow-up MRI patients at 1 year
Secondary follow-up CgA Follow-up MRI patients at 1 year
Secondary Surgery after follow-up MRI Follow-up with MRI patients up to 10 years
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