Study Summary
This trial will compare early surgery to non-operative management for people with appendicitis who also have an infection.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: More than 7 days after index admission but within 60 days of randomization.
30 days after randomization.
Gastrointestinal (GI) quality of life
Day 60
Intra-abdominal abscess
One year after randomization.
GI quality of life
Day 60
Complications
Days of disability
Failed attempted procedure.
Need for bowel resection
Need for bowel resection.
Number of hospital days
Number of interventions for abscess
Within one year of index admission.
Occurrence of delayed appendectomy
Presence of malignancy in any resected specimen
Recurrence
Within one year of the index admission.
Need for additional intervention for appendicitis
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Non-operative management
1 of 2
Surgery
1 of 2
Active Control
Experimental Treatment
180 Total Participants · 2 Treatment Groups
Primary Treatment: Operative management · No Placebo Group · N/A
Surgery
Procedure
Experimental Group · 1 Intervention: Operative management · Intervention Types: ProcedureNon-operative management
Other
ActiveComparator Group · 1 Intervention: Drainage or antibiotics · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Operative management
2012
N/A
~230
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: more than 7 days after index admission but within 60 days of randomization.
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,679 Previous Clinical Trials
21,087,873 Total Patients Enrolled
1 Trials studying Appendicitis
20 Patients Enrolled for Appendicitis
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Mentula, Panu, Henna Sammalkorpi, and Ari Leppäniemi. 2015. “Laparoscopic Surgery or Conservative Treatment for Appendiceal Abscess in Adults? A Randomized Controlled Trial”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000001200.
- Mentula P, Sammalkorpi H, Leppaniemi A. Laparoscopic Surgery or Conservative Treatment for Appendiceal Abscess in Adults? A Randomized Controlled Trial. Ann Surg. 2015 Aug;262(2):237-42. doi: 10.1097/SLA.0000000000001200.
- 2020. "Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04168866.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments