Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04634448
Study type Interventional
Source Turku University Hospital
Contact Paulina Salminen, prof, MD
Phone +35823130000
Email paulina.salminen@tyks.fi
Status Not yet recruiting
Phase N/A
Start date December 1, 2020
Completion date December 31, 2035

See also
  Status Clinical Trial Phase
Completed NCT04529980 - Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis N/A
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Recruiting NCT03522233 - Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
Recruiting NCT03380793 - A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis Phase 4
Recruiting NCT02108340 - Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis N/A
Terminated NCT02029781 - The Laparoscopic Appendicitis Score; a Multicenter Validation Study N/A
Completed NCT01356641 - Antibiotic Treatment Alone for Acute Simple Appendicitis in Children N/A
Completed NCT01515293 - Single Incision Versus Conventional Laparoscopic Appendectomy Phase 3
Terminated NCT00971438 - Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging N/A
Completed NCT00913380 - Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT Phase 3
Completed NCT00530998 - Minimally Invasive Surgery: Using Natural Orfices
Completed NCT00616616 - Single Incision Laparoscopy N/A
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT02916134 - Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis N/A
Completed NCT04614649 - Right Iliac Fossa Treatment-Turkey Audit
Completed NCT04365491 - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
Completed NCT03770897 - Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome N/A
Completed NCT02507674 - Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
Active, not recruiting NCT01718275 - Non-operative Management of Early Appendicitis in Children
Terminated NCT01575028 - Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies Phase 2