An interventional study of Interval appendectomy and Follow-up MRI at 1 year in Appendix Abscess, Appendicitis and Appendix Mass, sponsored by Turku University Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 400 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Turku University Hospital is the lead sponsor of 287 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
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
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
interval appendectomy at 2 to 3 months after the initial non-operative treatment
follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery
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
Time frame: 2-3 months (interval appendectomy)
Tympanic temperature
All patients
Time frame: Day 0 (on primary admission)
Imaging (primary diagnosis) finding
All patients
Time frame: Day 0 (on primary admission)
Duration of symptoms on admission
All patients
Time frame: Day 0 (on primary admission)
Laboratory value: CRP
CRP
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Laboratory value: leuckocytes
leuk
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Laboratory value: neutrophils
neutr
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Laboratory value: hemoglobin
Hb
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Laboratory value: kreatinine
Krea
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Laboratory value: CEA
CEA
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital) and up to 1 year, if no interval appendectomy
Laboratory value. Cg-A
Cg-A
Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)and up to 1 year, if no interval appendectomy
Primary nonoperative treatment
All patients, treatment details
Time frame: Day 0 and up to one week
Colonoscopy: endoscopic findings and histology
In both intervention groups
Time frame: 2 weeks to 2 months prior to planned interval appendectomy
Interval appendectomy specimen histology
Interval appendectomy patients
Time frame: At 3 months
Complications after interval appendectomy
Clavien-Dindo classification, interval appendectomy group
Time frame: at the time of surgery
Duration of hospital stay
All patients both at primary treatment, interval appendectomy and follow-up
Time frame: up to 2 years
Follow-up MRI findings
In case the patient does not under interval appendectomy
Time frame: at 1 year
follow-up CEA
Follow-up MRI patients
Time frame: at 1 year
follow-up CgA
Follow-up MRI patients
Time frame: at 1 year
Surgery after follow-up MRI
Follow-up with MRI patients
Time frame: up to 10 years
No study locations are listed for this record.
Plan to share: Yes — IPD is available from the PI upon request, if needed.
Supporting information: Study protocol, Statistical analysis plan
Time frame: At study completion
Access criteria: Please see above.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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